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The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
FDA sent a warning letter to Baoying County Fukang Medical Appliance Co., Ltd. on Dec. 8, 2016 detailing violations inspectors observed during an FDA inspection of the company’s Yangzhou City facility from June 6–9, 2016. Violations ranged from limiting the FDA inspection to quality control issues. The warning letter states that the company has not provided the agency with a corrective action and preventive action plan to address the violations. FDA placed the facility, located at Suzhong Trade of City Private Industrial Park, Baoying County, Yangzhou City, Jiangsu Province, on Import Alerts 66-40 and 99-32 on Sept. 20, 2016.
According to the FDA warning letter, a company representative refused to provide FDA with information regarding the company’s microbiological testing processes during the inspection on June 6, 2016. The full test procedure was not provided to FDA. FDA stated, in the letter, that “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.”
A variety of quality issues were observed by FDA inspectors during their visit. The company lacked written procedures for production or quality unit responsibilities. The letter stated that the company does not perform microbiological analysis of final products before release to the US market nor does it perform assay testing on its over-the-counter drug products to verify identity and strength of API. Requests for chemical analysis records for products released to the US were ignored.
A failure in facility quality was also observed by investigators. “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.”
Personnel washing facilities in working areas were absent. Inspectors found the only on-site toilet facility contained no running water and visible sewage and was shared by production, quality, and administrative personnel.
The facility was put on import alert by FDA and the agency stated, “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).”