Environmental Health & Safety

Japanese API Maker Blocks FDA Inspection

By Chemical Processing Staff

Oct 11, 2016

Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical reportedly obstructed a Food and Drug Administration (FDA) inspection at the company’s Takasago city facility last December and drew a harsh warning from the FDA in response. According to an article posted on the Regulatory Affairs Professionals Society (RAPS) website, Nippon employees physically blocked FDA inspectors from completing parts of their inspection, refused to turn over records and prevented inspectors from taking photographs of equipment at the facility.

According to the article, a quality control manager for Nippon directed employees to stand shoulder-to-shoulder to prevent FDA inspectors from accessing parts of the lab and equipment that is used to analyze drugs for distribution to the U.S. The FDA’s request for records reportedly came after a review of customer complaints that Nippon products contained "glass, hair, cardboard, metal, product discoloration and a black spider." NAPS reports that the FDA will continue to refuse shipments from Nippon’s Takasago City facility until it can re-inspect the facility and ensure it is in compliance with current good manufacturing practice (cGMP). Further, the FDA reportedly considers the company’s products to be adulterated under CFR 21 Section 351(j).

Read the entire article here.