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FDA Warns Japanese Company for Impeding Inspection

Posted 06 October 2016 | By Michael Mezher 

FDA Warns Japanese Company for Impeding Inspection

The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

According to FDA, Nippon Fine Chemical employees physically blocked an FDA investigator from conducting portions of the inspection, refused to hand over records and prevented FDA from taking photographs of equipment at the facility.

FDA says a quality control manager for the company told 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."

Then, after reviewing complaints from customers that Nippon Fine Chemical's products contained "glass, hair, cardboard, metal, product discoloration, and a black spider," FDA says the company refused to provide copies of records for the products.

Additionally, FDA says the company's quality assurance manager prevented the investigator from taking photographs of certain equipment used to make drugs destined for the US.

Following the inspection, FDA says it received five responses from the company, one of which from the company's legal counsel; however, the agency says shipments from the company's Takasago City facility will continue to be refused until it is able to re-inspect the facility and ensure it is in compliance with current good manufacturing practice (cGMP).

As a result, FDA says it considers the company's products to be adulterated under CFR 21 Section 351(j), which states that a drug or device is considered to be adulterated if "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."

Warning Letter


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