FDA slaps Japanese drugmaker with warning letter for stymying inspection

The FDA hit Japanese drug manufacturer Nippon Fine Chemical with a warning letter for obstructing an inspection at its plant last year.

In the letter dated Sept. 26, 2016, which was recently posted on the regulatory agency’s website, the FDA said that during an attempted inspection in Dec. 2015, the firm "limited and/or refused an FDA inspection."

Investigators were limited in their access to the facility located in Takasago City, and at one point an NFC manager directed employees to form a human barrier by standing shoulder to shoulder to block access to areas of the laboratory and equipment used to analyze drugs destined for U.S. distribution.


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Additionally, the company refused to provide copies of documents that included customer complaints of drugs it had manufactured. These complaints said the drugs contained glass, hair, cardboard, metal, product discoloration and in one case, a black spider. The company also prevented the inspector from taking photographs of equipment at the facility.

Nippon Fine Chemical manufactures certain drugs for the Japanese and U.S. markets using the same equipment and processes, and divides lots for distribution between the two.

In early August, the agency placed the company on its Import Alert list, which effectively bans its products from entering the U.S. Until the company complies with FDA inspections, the agency can withhold approval of any new applications or supplements of drugs that are manufactured at the facility.

- check out the warning letter

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