Nippon Fine Chemical recently received a Form FDA 483 (December 14, 2015), followed by an Import Alert (August 8, 2016) and a Warning Letter (Click Here) (September 26, 2016) for adulterated products that were produced at their drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo. The FDA investigator 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 drugs 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.
Your firm limited an inspection and/or refused to permit the FDA inspection as follows:
- Barring access to areas
During the inspection, your firm limited the investigator’s access to the quality control laboratory. The quality control manager directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution.
- Refusal to provide copies of documents
Your firm manufactures certain drugs for the Japanese and U.S. markets using the same equipment and processes, and divides lots for distribution between the two markets. During the inspection, our investigator reviewed complaints you received about your drugs from your customers, including complaints that your drugs contained glass, hair, cardboard, metal, product discoloration, and a black spider. Your firm limited the inspection by refusing to provide FDA copies of these records.
- Limiting photography
During the inspection, our investigator attempted to take pictures of the (b)(4) apparatus used to manufacture drugs for U.S. distribution. Your quality assurance manager impeded the inspection by preventing our investigator from photographing this piece of equipment.
21 U.S. Code 351 – Adulterated Drugs and Devices states: “(j)Delayed, denied, or limited inspection; refusal to permit entry or inspection
If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.