Triceutical Inc./Zhamg 11/8/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
November 8, 2012
WARNING LETTER NYK-2013-3
VIA OVERNIGHT MAIL
Mr. Liqun Zhang, President
164 Milbar Blvd.
Farmingdale, NY 11735
Dear Mr. Zhang:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 226B Sherwood Ave, Farmingdale, NY, and your dietary supplement packaging facility, located at 164 Milbar Blvd, Farmingdale, NY, on May 16 through May 29, 2012, and identified serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
The inspection revealed the following significant violations of the dietary supplement CGMP requirements:
1. Your firm did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to use, as required in 21 CFR 111.75(a)(1)(i), and you did not petition FDA under 21 CFR 111.75(a)(1)(ii) for an exemption from such testing. Specifically, you did not perform any tests to verify the identity of the dietary ingredients used to manufacture the following finished dietary supplements: Joint King (lot nos. 1011311 & 213612), Fiber Cleanse II (lot no. 416012), and Protein Powder-Pineapple (lot no. 516112), Protein Powder-Regular (lot no. 516412), Protein Powder-Orange (lot no. 313912).
2. Your firm did not verify that either every finished dietary supplement batch or a subset of finished dietary supplement batches that you identify through a sound statistical plan meet product specifications for identity, purity, strength, and composition, as required in 21 CFR 111.75(c). Specifically, you did not verify that your finished batches of Joint King (lot nos. 1011311 & 213612), Fiber Cleanse II (lot no. 416012), and Protein Powder-Pineapple (lot no. 516112), Protein Powder-Regular (lot no. 516412), Protein Powder-Orange (lot no. 313912) meet product specifications for identity, purity, strength, and composition.
3. Your firm’s master manufacturing records failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specification identified in accordance with 21 CFR 111.205(b)(1), as required in 21 CFR 111.205(b)(2). Specifically, your firm’s master manufacturing records for Joint King (lot nos. 1011311 & 213612), Fiber Cleanse II (lot no. 416012), and Protein Powder-Pineapple (lot no. 516112), Protein Powder-Regular (lot no. 516412), Protein Powder-Orange (lot no. 313912) failed to include the following information required by 21 CFR 111.210:
· A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
· A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finished manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
· A representative label or a cross reference to the physical location of the actual or representative label for finished products that are packaged and labeled [21 CFR 111.210(g)].
4. Your firm did not prepare a batch production record every time you manufactured a batch of a dietary supplement, as required in 21 CFR 111.255(a) and in accordance with 21 CFR 111.260. Specifically, your firm did not prepare batch production records every time a batch of dietary supplements is manufactured for finished Joint King (lot nos. 1011311 & 213612), Fiber Cleanse II (lot no. 416012), and Protein Powder-Pineapple (lot no. 516112), Protein Powder-Regular (lot no. 516412), Protein Powder-Orange (lot no. 313912) to ensure proper control of each batch.
5. Your firm’s quality control operations did not include approving and releasing, or rejecting, each finished batch of dietary supplements for distribution, as required in 21 CFR 111.123(a)(8). Specifically, your firm is packing and labeling dietary supplements for further distribution, however your firm’s quality control operations does not include approving/releasing or rejecting finished lots of any finished batches of dietary supplements for distribution.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
We note, our inspection also revealed that a qualified person did not investigate a product complaint that involved the possible failure of a dietary supplement to meet a specification, or other requirement 21 CFR Part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, as required in 21 CFR 111.560(a)(2). In January 2012, your records indicate that your firm received a product complaint from one of your customers regarding the dietary supplement, Joint King (lot no. 910511). Your firm failed to document this complaint and conduct an investigation as required by your firm’s SOP #6 and 21 CFR 111.560(a)(2).
Under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements no later 15 business days after a report of the event is received through the address or phone number provided on your dietary supplement products. Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within 15 business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found online in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” available on our website, www.fda.gov.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations, and include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District