FDA Warns Japan API Maker for Forming Human Barricade to Stop Inspection

Oct 09, 2016

The FDA has warned Japanese active pharmaceutical ingredient maker Nippon Fine Chemical Co. for physically blocking an FDA investigator from conducting portions of the inspection at the company's plant in Takasago City, Japan.

According to the FDA, a quality control manager for Nippon ordered employees to "stand shoulder-to-shoulder, barring [the] investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution."

Additionally, the FDA reported that during the inspection, the investigator reviewed complaints that Nippon received about its drugs from customers, including complaints that drugs contained glass, hair, cardboard, metal, product discoloration, and a black spider. According to the FDA, the firm "limited the inspection by refusing to provide FDA copies of these records."

As a result, FDA says it considers the company's products to be adulterated under CFR 21 Section 351(j).

Read the Warning Letter