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FDA Drug & Medical Device Recall News & Comments 
Tuesday, December 28 2010

December 28, 2010

WARNING LETTER

Via UPS


Kelly D. Harvey, President
NovaCare, LLC (TSN Labs, Inc.)
330 West 6100 South
Salt Lake City, UT  84047

Ref: # DEN-11-06-WL

Dear Mr. Harvey:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above from March 8, 2010 through March 22, 2010.  During the inspection samples were collected of your firm's (b)(4) an ingredient used by your firm in the manufacture of products marketed as dietary supplements, and of the Master Manufacturing Records for products manufactured by your firm, which show (b)(4) as a component in their production.  Laboratory analyses conducted by the FDA concluded that your firm's (b)(4) contains sulfoaildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED).  Following this finding, FDA obtained samples of products manufactured by your firm and marketed as dietary supplement including, but not limited to, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX,"  "Zilex," and "Zotrex."1   For the reasons stated below, these  products are unapproved drugs in violation of section 505(a) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(a)] and misbranded drugs in violation of sections 502(f)(1) [21 U.S.C. 352(f)(1)], 502(f)(2) [21 U.S.C. 352(f)(2)] and 502(a) [21 U.S.C. 352(a)].  In addition, [(b)(4) is a drug within the meaning of section 201(g)(1)(D) [21 U.S.C. 321(g)(1)(D)] of the Act and is misbranded under section 502(f)(1) [21 U.S.C. 352(f)(1)] of the Act.  

Your firm's sexual enhancement products "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are labeled with claims such as the following:

"Aziffa"

? "Male Sexual Stimulant"
? "Sexual Stimulation Blend"

 "MONSTER EXCYTE"

? "INCREASED SEX DRIVE, STAMINA AND VIRILITY FOR MEN"
? "MALE SEXUAL VITALITY ENHANCER"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"

"Natural WOW! Ultra Perform for MEN"

? "SEXUAL BOOSTER!"
? "INCREASES STAMINA"
? "BOOSTS SEXUAL APPETITE"
? "INCREASES SEXUAL VITALITY"
? "take one capsules 30-45 minutes before sexual activity"

"Natural WOW! Ultra Perform for WOMEN"

? "SEXUAL BOOSTER!"
?  "BOOSTS SEXUAL APPETITE"
? "INCREASES FEMALE SEXUAL VITALITY"
? "take one capsules 30-45 minutes before sexual activity"

"OMG"

? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"
? "OMG Vitality Formula"

"ProLatis'"

? "All-Natural Male Performance Pill"
? "Take 1-2 capsules 1-2 hours before sexual activity."

"Stiff Nights"

? "Male Sexual Stimulant"
? "Regain the Thunder"
? "Erection Booster BlendTM"

"Verect"

? "Male Sexual Vitality"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity."
? "Zotrex Vitality Formula"

"XaitriX"

? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity"

"Zilex"

? "Female Sexual Vitality"
? "Zilex Vitality Formula"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water."

"Zotrex"

? "Male Sexual Vitality"
? "Zotrex Vitality Formula"
? "As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water"

These statements make clear that the above mentioned products are drugs under section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)] because they are intended to affect the structure or function of the human body.  Your firm's "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" sexual enhancement products are labeled as dietary supplements.  However, these products contain sulfoaildenafil, a phosphodiesterase type 5 (PDE5) inhibitor and an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED).  Sulfoaildenafil is a synthetic active pharmaceutical ingredient and is not a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)].

Under section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)] or the product is subject to regulation as a drug.  Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body.  However, the structure/function claims quoted above do not describe the effects of nutrients or dietary ingredients in the products.  Rather, the claims are made for the products as a whole and relate to their sulfoaildenafil content.  Since sulfoaildenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)], but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)].  Accordingly, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are drugs within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)].

Furthermore, under section 201(g)(1)(D) of the Act [21 U.S.C. 321(g)(1)(D)], an article intended for use as a component of a drug is also a drug.  Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.  See Title 21 of the Code of Federal Regulations, Part 210.3(b)(3) [21 CFR 210.3(b)(3)].  Master Manufacturing Records obtained from your firm indicate that (b)(4) is an ingredient used in the manufacture of drugs, including, but not limited to "Zotrex."  Accordingly, your firm's (b)(4) is a drug within the meaning of section 201(g)(1)(D) of the Act [21 U.S.C. 321(g)(1)(D)]. 

Moreover, "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are new drugs, as defined by section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.  Under sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.  Your distribution or sale of these products without an approved application violates these provisions of the Act.

"Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are "prescription drugs" as defined at section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)] because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them.  Indeed, all FDA approvals of PDE5 inhibitors are limited to use under the professional supervision of a practitioner licensed by law to administer such drugs.

According to section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s).  "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR 201.5]. 

Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner.  Therefore, it is impossible to write "adequate directions for use" for prescription drugs.  FDA-approved drugs that bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson [21 U.S.C. 201.100(c)(2) and 201.115].  Because there is no FDA-approved application for "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex," their labeling fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

In addition, a drug in bulk package form intended for use in the manufacture of a new drug is only exempt from section 502(f)(1) of the Act [21 CFR 352(f)(1)] if it satisfies the specific conditions set forth in 21 CFR 201.122.  Your bulk package drug (b)(4) does not satisfy the conditions of the exemption. Thus, your firm's (b)(4) is also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

Under section 502(a) of the Act [21 U.S.C. 352(a)], a drug is misbranded if its labeling is false or misleading in any particular.  Section 201(n) of the Act [21 U.S.C. 321(n)] provides that in determining whether a drug's labeling or advertising "is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts material in light of such representations . . . ."  The labeling of the above mentioned products does not declare that they contain sulfoaildenafil.  Sulfaoaildenafil is an analogue of sildenafil, and, like sildenafil, is a PDE5 inhibitor.  Because it is an analogue of sildenafil, sulfoaildenafil likely exhibits similar pharmacological action to sildenafil.  The use of PDE5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events.  The undeclared PDE5 inhibitor in the above mentioned products may pose a serious health risks because patients with underlying medical issues may take these products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking.  For example, PDE5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  Further, patients who have been advised against taking PDE5 inhibitors because of comorbidities or potential drug interactions may seek products like "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" because they are marketed as not containing the active ingredients in approved ED drugs.  The failure to disclose the presence of sulfoaildenafil renders your products' labeling false and misleading.  "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are therefore misbranded under Section 502(a) of the Act [21 U.S.C. 352(a)]. 

"Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" are also misbranded under Section 502(f)(2) of the Act, [21 U.S.C. 352(f)(2)] in that their labeling lacks adequate warnings for the protection of users.  As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes them would be unaware of the presence of sulfoaildenafil.  For example, because sulfoaildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume "Aziffa," "MONSTER EXCYTE," "Natural WOW! Ultra Perform for MEN," "Natural WOW! Ultra Perform for WOMEN," "OMG," "ProLatis'," "Stiff Nights," "Verect," "XaitriX," "Zilex," and "Zotrex" may be at risk of life-threatening hypotension.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act (21 U.S.C. 331).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your reply should be sent to the Food & Drug Administration, Denver District Office, Denver Federal Center - Building 20, 6th Avenue and Kipling Street, P.O. Box 25087, Denver, CO 80225-0087, to the attention of Thomas R. Berry, Compliance Officer.  If you have any questions regarding the content of this letter, please contact Mr. Berry at (303) 236 -3028.

 

Sincerely,

/s/

H. Thomas Warwick, Jr.
Denver District Director

Posted by: DW AT 09:55 am   |  Permalink   |  Email
Thursday, December 16 2010

WARNING LETTER - PROGRAM DISAPPROVAL

Dec. 16, 2010

Mr. Ronald Poe, Owner
Mega Sun, Inc.
4515 Miami St.
Saint Louis, MO 63116-1707

Dear Mr. Poe:

This letter notifies you that the United States' Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), hereby disapproves the quality control and testing program for your firm's sunlamp products including, but not limited to Models Megasun Slimline, Megasun Extreme, Megasun Crossfire and Megasun Mega V produced by Mega Sun, Inc., Saint Louis, MO. This action is taken under the authority of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C Electronic Product Radiation Control, Section 534(h) [U.S.C. 360kk(h)].

This disapproval means that your firm is prohibited by Sections 534(h) and 538(a) of the Act from:

1. Certifying the electronic products manufactured under the disapproved testing program ( 538(a)(5)(B)),

2. Introducing, delivering for introduction, or importing into U.S. commerce any product which does not comply with the applicable standard ( 538(a)(1)), and

3. Introducing or importing into U.S. commerce any product which does not have a certification as required by section 534(h) and ( 538(a)(5)(A)).

A significant failure to comply with the requirements of the applicable performance standards was discovered during review of an establishment inspection report submitted by Ms. Kelly Sheppard and Mr. Eric Padgett, investigators of the FDA's Kansas District Office. Ms. Sheppard and Mr. Padgett's report was based on their July 27 and August 11, 2010 inspections of Mega Sun, Inc. Based on the findings listed below, CDRH finds that Mega Sun, Inc. failed to establish a quality control and testing program which ensures compliance with the applicable performance standards. Sunlamp products  manufactured on or after May 7, 1980, are subject to the requirements of the Federal performance standard for sunlamp products (Title 21 CFR 1040.20) as well as the general performance standard for electronic products (Title 21 CFR 1010). Mega Sun, Inc. has also failed to comply with requirements for reports and record keeping (Title 21 CFR 1002).

Specifically, your sunlamp products fail to comply with:

1. 21 CFR 1010.2(c) Certification

a. The firm's sunlamp products failed to be certified based upon a quality control and testing program in accordance with good manufacturing practices. Specifically, because your firm did not maintain any manufacturing quality control or test records for sunlamp products entered into commerce, there is no evidence that an adequate quality control and testing program exists which ensures your sunlamp products comply with the performance standard.

You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of sunlamp products which have been produced and the number of such products that have left the place of manufacture.

Additionally, you have 15 days after you receive this letter to respond in writing using one of the options listed below:

1. Refutation. Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.

2. Exemption Request. Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements (21 CFR 1003.10(b)). If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.

3. Purchaser Notification and Corrective Action. If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.

a. Notification Letter. Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the  notification letter(s) sent to purchasers and dealers must also be sent to the FDA. We recommend that you submit a draft of this letter to us for review.

b. Corrective Action Plan (CAP). Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must
expeditiously correct the failure to comply with the performance standard and must be approved as set out in 21 CFR 1004.6.

If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11 (c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.

The following failures to comply with regulations regarding reports and record keeping were noted during a review of the establishment inspection report prepared by the FDA's Kansas District Office and a review of our records:

1. 21 CFR 1002.30(a)(1), 1002.30(a)(2), 1002.30(a)(4) Records to be maintained by manufacturers. The firm failed to maintain the following records:

a. Description of the quality control and testing procedures with respect to electronic product.

b. Results of tests for electronic product radiation safety including the control of unnecessary, secondary or leakage of radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.

c. Copies of communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed products.

2. 21 CFR 1002.10, 1002.11 Product reports, Supplemental reports. The firm failed to submit a product or supplemental report for each sunlamp product model or model family it manufactured and entered into commerce.

3. 21 CFR 1002.13 Annual Reports. The firm failed to submit annual reports for products it manufactured and entered into commerce.

Section 538(a) of the Act, Chapter V, Subchapter C Electronic Product Radiation Control prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the performance standard. It is also a prohibited act to fail to establish and maintain required records and failure to submit required reports. Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.

In summary, to address these violations you must:

1. Submit a corrective action plan that addresses the failure to certify sunlamp products based on a quality control testing program as required by 21 CFR 1010.2(c) Certification. As indicated above you may refute the failures to comply and/or request an exemption from your responsibility to notify dealers, distributors and purchasers as described above. The regulations associated with each of these options lists the specific information required to provide a complete response.

In order for FDA to evaluate plans to correct your quality control testing program, you must provide the following items in your response:

1. A complete description of the quality control testing program, to include policies, procedures, forms and other documentation, you will use to certify your sunlamp products prior to entering those products into commerce. Include at least one set of test data and quality control records that were generated using the submitted procedures. Your quality control testing program must be documented by submission of a product or supplemental report as required by 21 CFR 1002.10 and 1002.11.

2. Documentation that your quality control testing program ensures safety and compliance of all models of sunlamp products which you intend to enter into commerce. If different models have unique features that create differences in radiation emission characteristics, how they comply with the sunlamp standard or how they are tested, your quality control testing program must account for those differences. Information on models having such unique features must be documented separately in supplemental reports as required by 21 CFR 1002.11.

3. Photographs depicting implementation of your quality control testing program at your factory. At a minimum these photographs must depict the following testing for each model of sunlamp product you currently produce:

? spectral measurements of emissions to ensure the exposure timer settings are accurate,
? calibration of each piece of test equipment (if you don't calibrate your own instruments provide a copy of outside calibration report(s)),
? use of test equipment during product compliance testing,
? placement of each required label, and
? use of the quality control form(s) used to record compliance with each of the performance standard's requirements.

In order for FDA to evaluate plans to notify purchasers and repair, replace or refund products already introduced into commerce, you must provide the following items in your response:

4. Distribution records to indicate number of sunlamp products produced and the number of such products that left the place of manufacture since you began introducing products into the US. Submit annual reports covering all models of sunlamp products entered into commerce over the last 5 years in order to bring your annual reporting up-to-date as required by 21 CFR 1002.13. Annual reports must include any communications with customers, service personnel, dealers, distributors, or regulatory agencies that reference radiation safety or radiation emissions.

5. A draft customer notification and CAP to bring products previously entered into commerce into compliance. At a minimum, your CAP should include a procedure for verifying that distributed products comply with all applicable requirements of the performance standards (21 CFR 1010 and 1040.20). The procedure must include a means of creating and maintaining a record of the tests and inspections made that confirm each product complies with all applicable requirements of the performance standard.

The CDRH will review this information and advise you whether your corrective actions are satisfactory. You may not resume introduction of sunlamp products into commerce until you establish an adequate quality testing program, complete any necessary production changes to assure compliance of all units to be entered into commerce, submit all required reports and report supplements, and receive written notification that CDRH approves your plans to correct quality testing program deficiencies. Further, it is possible that CDRH will not approve your plan or will require additional actions; therefore, we recommend that you do not pursue correction of products already entered into commerce until you receive written notification that CDRH approves your plans to bring those products into compliance.

Copies of the Federal Performance Standards, compliance guides, radiation safety lproduct report guides, and other documents related to sunlamp products are available on FDA's web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm1.

Your response should be sent to:

Chief, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., W066-4621
Silver Spring, Maryland 20993-0002

If you have any questions regarding the content of this letter, you may contact Sharon Miller, Electronics Engineer at (301) 796-2471 or by email to SharonA.Miller@fda.hhs.gov.

Sincerely,

/s/

Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health

Posted by: DW AT 09:57 am   |  Permalink   |  Email
Thursday, December 02 2010

WARNING LETTER

DEC. 2, 2010

VIA UNITED PARCEL SERVICE & FACSIMILE

Mr. Michael Plew
Vice President of Quality and Regulatory Compliance
LifeNet Health
1864 Concert Drive
Virginia Beach, VA 23453

RE: MatrACELL Pulmonary Artery Patch Allograft

Dear Mr. Plew:

Refer to CMS #128430 when replying to this letter

The Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your July 27, 2010 response to our letter, dated July 14, 2010, regarding promotional claims made for the MatrACELL? Pulmonary Artery Patch Allograft (MatrACELL? Allograft). FDA has determined that your response is inadequate and that your firm is marketing the MatrACELL? Allograft in the United States (U.S.) for a new intended use without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA reviewed your website, http://www.lifenethealth.org/1, for the MatrACELL? Allograft on July 14, 2010. The MatrACELL? Allograft is a device within the meaning of Section 201(h) of the Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. 
 
As we noted in our letter dated July 14, 2010, your promotional materials, which appear on your website at http://www.lifenethealth.org/2, promote the MatrACELL? Allograft for the claim of "reduced immune response." FDA cleared your premarket notification (510(k)) for the MatrACELL? Allograft, K081438, for repair of the right ventricular outflow tract. However, the MatrACELL? Allograft has not been cleared for the claim of "reduced immune response."  This claim represents a major change or modification in the intended use of your device that requires a new premarket notification. 21 CFR 807.81(a)(3)(ii).
 
The MatrACELL? Allograft is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e (a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for the new intended use discussed above, as required by sections 510(k) of the Act, 21 U.S.C. 360(k) and 21 CFR 807.81(a)(3)(ii).
 
FDA requests that LifeNet immediately cease marketing the MatrACELL? Allograft for unapproved uses such as those described above.  You should take prompt action to correct these violations.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
 
We suggest LifeNet Health contact the Peripheral Vascular Devices Branch, Office of Device Evaluation at (301) 796-6376 to discuss the submission of a premarket notification (510(k)) for any proposed new intended use of the MatrACELL  Allograft.
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for MatrACELL? Allograft containing claims for unapproved uses such as those described above, and explain your plan for discontinuing use of such claims.  Please direct your response to Daniel G. Walter, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B, WO66, Room 3678, Office of Compliance, at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, facsimile at (301) 847-8139.  We remind you that only written communications are considered official.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for MatrACELL? Allograft comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiologial Health

Posted by: DW AT 10:00 am   |  Permalink   |  Email
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This is an Attorney / Lawyer Advertising Website. It is not a medical information, medical dictionary, medical advice or medical help site. Talk to you own treating Doctor about any questions or concerns that you have concerning any medicine, drug, medical device or treatment plan. Do not rely on any information on this site to alter, stop or change any medication or treatment plan by your prescribing or treating Doctor. Many of the drugs and devices listed here on this site have published risk and warnings associated with their use and have not been recalled. This website is not in anyway connected with any drug company or the FDA.Check with your Doctor, Pharmacy and/or the FDA as to any concerns as to their use, recall status and safety. See http://www.fda.gov/ for the latest information.

Principal Office -Willis Law Firm 5005 Riverway Drive, Suite #160 Houston, Texas 77056

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