Baoying County Fukang Medical Appliance Co., Ltd. 12/8/16
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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 320-17-09
Return Receipt Requested
December 8, 2016
Mr. Yikai Fu
Baoying County Fukang Medical Appliance Co., Ltd.
Huangcheng Town Industrial Area
Baoying County, Jiangsu Province
Dear Mr. Fu:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Baoying County Fukang Medical Appliance Co., at Suzhong Trade of City Private Industrial Park, Baoying County, Yangzhou City, Jiangsu Province, from June 6 to 9, 2016.
Our investigators documented that your firm limited and/or refused an FDA inspection. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), your drug products are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.
Our investigators also documented that your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP. Therefore your drug products are also 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).
On June 6, 2016, you signed a “declaration” saying you would (b)(4), and on June 8, 2016, you signed a “declaration” saying that your firm would (b)(4). We have not received a response from your firm for corrective actions to the violations identified during the inspection.
This warning letter summarizes your limitation of an inspection and significant deviations from CGMP for drug manufacturing. Our investigators observed specific deviations including, but not limited to, the following.
1. Your firm delayed, denied, or limited an inspection, or refused to permit the FDA inspection.
On June 6, 2016, during the inspectional walk through of the laboratory testing area of your facility, our investigator asked you to explain the microbiological testing processes used on the (b)(4) that you manufacture and distribute to the United States. Your firm’s representative stated he would not disclose the firm’s trade secrets. Our investigator explained that as part of the inspection, FDA needs to know the details of the operations, and that FDA does not disclose details of the information. Nonetheless, without reasonable explanation, the full test procedure was never provided.
2. Your firm failed to establish an adequate 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))
During the investigation, our investigator found your firm has no written procedures for production or quality unit responsibilities. Among other things, your quality unit approved and released (b)(4) and (b)(4) for distribution to the U.S. market. Your firm approved these products for release even though your quality unit had no assurance that they met specifications or that they were manufactured under adequate controls.
3. 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))
Your firm manufactures (b)(4) labelled “For (b)(4).” Your firm stated to the investigator that you do not perform microbiological analysis of your final products prior to release to the U.S. market. In addition, you informed our investigator that you do not perform assay testing for your over-the-counter (OTC) drug products to verify the identity and strength of the active ingredients prior to release. Your firm also failed to provide requested records for chemical analyses performed for products released to the U.S. market.
4. Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin. (21 CFR 211.56(a))
Our investigator documented copious amounts of unknown black, mold-like material on the floor and walls of warehouse #2. In addition, our investigator observed standing water on the floor and live insects at the entrance of the same warehouse. This warehouse is a storage area for (b)(4) used in the production of your firm’s (b)(4). The poor conditions in your facility could compromise the quality of the products you manufacture.
5. Your firm failed to provide adequate washing facilities, including hot and cold water, soap or detergent, air driers or single service towels, and clean toilet facilities easily accessible to working areas. (21 CFR 211.52)
There was no adequate washing facility accessible to working areas at your site. Additionally, the only toilet facility on-site contained visible sewage and had no running water. This toilet facility is shared by production, quality, and administrative personnel at your facility.
6. Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures. (21 CFR 211.80(a))
Specifically, your firm receives drums of (b)(4) raw material from your supplier without any identifying labels. Your firm does not perform identity testing or any other analysis onincoming raw materials upon receipt or prior to use, and you have no procedure that permits you to trace the source of the (b)(4) in each batch of finished products.
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.
FDA placed your firm, located at Suzhong Trade of City Private Industrial Park, Baoying County, Yangzhou City, Jiangsu Province, on Import Alerts 66-40 and 99-32 on September 20, 2016.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Baoying County Fukang Medical Appliance Co., Suzhong Trade of City Private Industrial Park, 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).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Carla A. Norris, Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI 3006795842.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research