- Austin Biotechnology Inc.
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993 |
Warning Letter 320-16-15
Return Receipt Requested
June 2, 2016
Ms. Yen Tsui Lee
Austin Biotechnology Inc.
10–15 No 42 Song Jiang Road
Taipei, Taiwan 10455
The U.S. Food and Drug Administration (FDA) inspected your pharmaceutical manufacturing facility, Austin Biotechnology Inc. at 10–15 No 42 Song Jiang Road, Zhongshan District, Taipei, Taiwan, from May 28 – 29, 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 reviewed your firm’s May 29, 2015 response in detail.
Our investigator observed specific violations, including, but not limited to, the following.
1. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products (21 CFR 211.22(a)).
2. Your firm failed to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that your firm’s drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
3. Your firm failed to ensure that its drug products bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
4. Your firm failed to establish and follow a 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)).
5. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).
In your response of May 29, 2015, you acknowledged the significance of the CGMP observations and “decided to stop the shipping and distribution of these products in the USA.” You did not commit to any corrective actions regarding the CGMP violations observed on the inspection.
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.
If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Using a consultant does not relieve your firm’s obligation to comply with CGMP. Notify this office, in writing, of the specific steps that you have taken to correct violations and prevent recurrence. Provide supporting documentation. If your firm cannot complete corrective actions, state the reasons and the date by which your firm will have completed the corrections.
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 refusing admission of articles manufactured at Austin Biotechnology Inc., 10 -15 No. 42 Song Jiang Road, Zhongshan District., Taipei, Taiwan 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:
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 3009474948.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research