| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesTelephone (973) 331-4908
March 1, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Yan Chen
President
Willing's Group, Inc.
1936 Olney Avenue Suite A
Cherry Hill, NJ 08003
File No.: 11-NWJ-12
Dear Ms. Chen:
On September 23 through September 29, 2010 the United States Food and Drug Administration (FDA) performed an inspection of your facility located at 1936 Olney Avenue, Suite A, Cherry Hill, New Jersey. Your firm packages and labels dietary supplements. Our investigators observed a number of serious violations of the Current Good Manufacturing Practices (CGMPs) in Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21 Code of Federal Regulations (CFR), Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that dietary supplements have been prepared, packed, or held under conditions that do not meet current good practice regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our' inspection on September 29,2010. You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
Your inspection revealed the following violations:
1. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Our investigators found that you did not prepare an MMR for any of your products.
Your October 6, 2010 response, which states that your firm will develop standard operating procedure documents for your packaging and holding operations, is inadequate in that it fails to include documentation of your corrective action. We will verify your MMRs during our next inspection.
2. You failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Our investigators found that no batch production records were prepared.
Your October 6, 2010 response, which states that your firm will prepare batch production records for each product packaged by your firm, is inadequate in that it fails to include documentation of your corrective action. We will verify your batch production records during our next inspection.
3. You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Our investigators found that your firm did not have procedures for packaging and labeling operations.
Your October 6, 2010 response, which states that your firm will establish written procedures for packaging and labeling operation, is inadequate in that it fails to include documentation of your corrective action. We will verify your written procedures during our next inspection.
4. You failed to establish and follow written procedures.for quality control operations to include procedures for conducting a material review, making a disposition decision, and rejecting or approving any reprocessing, as required by 21 CFR 111.103. Specifically, you had no written procedures for these functions.
Your October 6, 2010 response, which states that your firm conducts required quality control operations, is inadequate in that it fails to address your lack of written procedures for quality control operations.
5. Your firm failed to make and keep documentation of training, including the date of the training, the type of the training, and the person(s) trained, as required by 21 CFR 111.14(b)(2). Although you told our investigators that you train all of your employees, you did not make or keep any documentation related to training.
Your October 6, 2010 response, which states that your firm will document future training, is inadequate in that it fails to include documentation of your corrective action. We will verify the documentation of your employee training during our next inspection.
6. You did not take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests, as required by 21 CFR 111.15(d)(2). Specifically, our investigators observed that the warehouse bay door of your facility had a noticeable gap of approximately two inches and that the side entrance was propped open during the investigation.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure that you comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in additional regulatory action without further notice including, but not limited to seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations and to prevent their recurrence. Your response should include any documentation necessary to show that the corrections have been achieved. If you cannot complete all corrections before you respond, state the reason for your delay and the date by which you will complete any remaining corrections.
Please send your reply to the U.S. Food and Drug Administration, Attention: Kerry Kurdilla at the address listed above. If you have questions regarding any issues in this letter, please contact Ms. Kurdilla at (973) 331-4908.
Sincerely,
/s/
Diana Amador-Toro
District Director
New Jersey District Office
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