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发表于 2016-8-3 00:37:22
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U.S. Food and Drug Administration
Protecting and Promoting Your Health
Xiamen Origin Biotech Co. Ltd. 7/19/16
Department of Health and Human Services
Public Health Service
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Warning Letter 320-16-22
Via UPS
Return Receipt Requested
July 19, 2016
Mr. Zhang Jian
Owner
Xiamen Origin Biotech Co., Ltd.
No. 7 Xiang Yue Road
Xiamen Torch, Xiamen
Fujian 361101
CHINA
Dear Mr. Zhang Jian:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facilities Xiamen Origin Biotech
Co., Ltd. (Attix Xiamen Pharmaceutical Co., Ltd.) at Unit D504 Jian Ye Building, 96 Xiangxing Road and No. 7
Xiang Yue Road, Xiamen Torch, Xiamen, Fujian, from January 18-20, 2016.
This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active
pharmaceutical ingredients (API).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to
CGMP, your API 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 deviations identified during the
inspection. We acknowledge your June 14, 2016, correspondence regarding placement of your firm on Import
Alert 66-40.
Our investigator observed specific deviations including, but not limited to, the following.
1. Failure to establish, document, and implement an effective system for managing quality.
Your firm had no written procedures for supplier qualification, relabeling operations, sampling, product release,
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document retention, or training. Your firm was unable to provide our investigator records for relabeling operations
from before September 2014.
2. Failure to transfer all quality or regulatory information received from the API manufacturer to your
customers.
You repeatedly falsified and omitted information on the certificates of analysis (CoA) you issued to your customers.
For example, your firm fabricated the name of an employee, and you used that name as the false signatory
authority on the CoA you sent to your customers. You also omitted the name and address of the original API
manufacturer and did not include a copy of the original batch certificate. Finally, you included an “expiration date”
on your CoA that exceeded the manufacturer’s labeled expiration date, but you had no basis for the extended
retest/expiry period.
Regulators and customers rely on CoA to provide accurate information regarding drug quality and pedigree.
Omitting and falsifying information on CoA compromises supply chain accountability and traceability and may put
consumers at risk.
3. Failure to keep buildings used in the manufacture of API in a clean condition.
During the inspection, the investigator recorded dirty warehousing spaces and observed a rodent in the room
adjacent to the warehouse at your facility.
Access to information during inspection
During the inspection, your firm also made misleading or deceptive statements and delayed the investigator’s
access to accurate and truthful information. For example:
During the inspection, an employee told the investigator that there were no drugs on site. The investigator
observed a room adjacent to the conference room that was being used as a warehouse for relabeled drugs.
The same employee told the investigator that your firm stopped relabeling drugs in January, 2015. However,
during the inspection, the investigator reviewed an exported drugs list that showed that your firm distributed
drugs after January 2015 and into January 2016.
When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be adulterated
under section 501(j) of the FD&C Act.We recommend that you review FDA’s guidance for industry Circumstances
that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
at: http://www.fda.gov/downloads/Reg ... ances/UCM360484.pdf
(http://www.fda.gov/downloads/Reg ... CM360484.pdf#_blank)
Conclusion
Deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these
deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations 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 deviations and to prevent their recurrence.
Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant
qualified to evaluate your operations and 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 ensuring ongoing CGMP compliance.
If you cannot complete corrective actions within 15 working days, state your completion date and reasons for
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delay.
Because of the findings of the FDA inspection described in this letter, your firm’s facilities were placed on Import
Alert 66-40 on May 13, 2016.
Until you completely correct all deviations and we confirm your compliance with CGMP, FDA may withhold
approval of any new applications or supplements listing your firm as an API manufacturer. Failure to correct these
deviations may also result in FDA continuing to refuse admission of articles manufactured at Xiamen Origin
Biotech Co., Ltd. (Attix Xiamen Pharmaceutical Co., Ltd.) at Unit D504 Jian Ye Building, 96 Xiangxing Road and
No. 7 Xiang Yue Road, Xiamen Torch, Xiamen, Fujian, 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:
Lynnsey Renn, Ph.D.
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov
Please identify your response with FEI 3010307355.
Sincerely,
/S/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
More in 2016
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