- Huzhou Aupower Sanitary Commodity
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
Via UPS Warning Letter 320-16-25
Return Receipt Requested
August 10, 2016
Mr. Xinhua Wang
Owner & General Manager
Huzhou Aupower Sanitary Commodity Co., Ltd.
Jingsan Road, Changxing Economic & Technical Development District
Huzhou City, Zhejiang, 313100
Dear Mr. Wang:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Huzhou Aupower Sanitary Commodity Co., Ltd., Jingsan Road, Changxing Economic & Technical Development District, Huzhou City, Zhejiang, from September 14–18, 2015.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We have not received a response from your firm for corrective actions to the violations identified during the inspection.
Our investigator observed specific violations including, but not limited to, the following.
1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
4. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
5. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities.
After you receive this letter, you have 15 working days to respond to this office in writing. Specify what you have done since our inspection to correct your violations and to prevent their recurrence.
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.
If you cannot complete corrective actions within 15 working days, state your completion date and reasons for delay.
Because of the findings of the FDA inspection described in this letter, your firm was placed on Import Alert 66-40 on August 5, 2016.
Until you completely correct all violations and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Huzhou Aupower Sanitary Commodity Co., Ltd., Jingsan Road, Changxing Economic & Technical Development District, Huzhou City, Zhejiang, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
Send your reply to:
Lixin (Leo) Xu, M.D., Ph.D.
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov
Please identify your response with FEI 3008618917.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research