Japanese API maker Sekisui Medical hit with FDA warning letter


For the second time in recent weeks, the FDA has slapped a Japanese API maker with a warning letter, this time predominantly for data integrity problems at Sekisui Medical.

According to the warning, which was issued Nov. 8 and posted on Tuesday, inspectors were in the plant in Hachimantai, Iwate in June. They said that among other things, the API maker was retesting products and not keeping results of failed tests.

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“Our investigator found that you failed to maintain complete data from all laboratory analyses, and that you relied on the incomplete information to determine whether your drugs met established specifications,” the warning letter says.

There were also problems with having data-collecting computer equipment protected against data deletions. An “analyst demonstrated to our investigator that he could change the data, including injection time and date, without the changes being captured in the audit trail, prior to printing the results.”

While the drugmaker has pledged to make changes to deal with the issues, the FDA wanted more and laid out a plan that included an investigation into the extent of the data failures and what products sent to the United States were affected. The agency suggested that Sekisui bring in outside experts to get a handle on how to fix its problems.

The warning letter to Sekisui comes weeks after the FDA also cited Nippon Fine Chemical. In that case, Nippon initially refused to let inspectors into the plant in Takasago City. In fact, at one point a manager had employees physically block access to areas of the laboratory and equipment used to analyze drugs by standing shoulder to shoulder. The investigator also was prevented from taking photos of equipment.

Nippon wouldn't provide copies of documents on customer complaints, which included concerns that some drugs contained glass, hair, cardboard, metal, product discoloration and in one case, a black spider. Nippon has been placed on the FDA’s Import Alert list which essentially bans its products from the United States.