Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Silver Spring, MD 20993|
VIA UPS WL: 320-16-03
RETURN RECEIPT REQUESTED
December 15, 2015
Mr. Chuen Fat Chan, Owner
Chan Yat Hing Medicine Factory
Flat 3, 9/F Fuk Keung Industrial Building
66-68 Tong Mei Rd.
From July 6-8, 2015, an investigator from the U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chan Yat Hing Medicine Factory located at Flat 3, 9/F Fuk Keung Industrial Building, 66-68 Tong Mei Rd., Mongkok, Kowloon, Hong Kong.
The FDA investigator identified significant violations from current good manufacturing practice (CGMP) for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.
These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
Please note that we have not received a response from your firm for corrective actions to the violations identified during the inspection.
Our investigator observed specific CGMP violations during the inspection, including, but not limited to, the following:
1. You failed to test finished batches of your drug products for the identity and strength of active ingredients (21 CFR 211.165(a)).
2. You failed to ensure the identity of components, including your active ingredients and excipients from various suppliers (21 CFR 211.84(d)(1) and (2)).
3. You have no data to demonstrate that the chemical and physical properties of your products remain acceptable throughout their (b)(4) shelf life (21 CFR 211.166(a)).
4. You failed to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that your drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
5. You failed to establish written responsibilities and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints (21 CFR 211.22(d)).
6. You failed to calibrate and maintain written records for the scale used to weigh components, including active ingredients, prior to their addition into the manufacturing process (21 CFR 211.68(a)).
Your quality unit released multiple batches of drug products for distribution, despite these and other violations.
Absent a response from your firm, we do not have sufficient details or supporting evidence to demonstrate that you have taken any corrective actions. As a result, your firm was placed on Import Alert 66-40 on December 3, 2015.
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating the violations identified above, determining their causes, preventing their recurrence, and preventing other violations.
Based upon the nature of the CGMP violations we identified at your firm, we recommend that you engage a third-party consultant with appropriate CGMP expertise to comprehensively assess your firm’s facility, procedures, processes, laboratory controls, and quality management systems to ensure that the drug products you manufacture are consistently of appropriate identity, strength, quality, and purity.
Until you complete all corrections, and FDA confirms corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Your failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Chan Yat Hing Medicine Factory located at Flat 3, 9/F Fuk Keung Industrial Building, 66-68 Tong Mei Rd., Mongkok, Kowloon, Hong Kong, into the United States under Section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
It is your responsibility to ensure your products contain only suitable inactive ingredients that are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity [21 C.F.R. 330.1(e)].
Within 15 working days of receipt of this letter, please notify this office, in writing, of the specific steps that you have taken to correct and prevent the recurrence of violations. Provide supporting documentation. If you cannot complete corrective actions within 15 working days, state the reasons for the delay and the date by which you will have completed the corrections. If you no longer manufacture or distribute the drug products at issue, provide the date(s) and reason(s) you ceased production. Send your reply to:
Philip Kreiter, Compliance Officer
U.S. Food and Drug Administration
White Oak 51 Room 4224
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Please identify your response with FEI # 3005440817.
Thomas J. Cosgrove, J.D.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research