Another Japanese drugmaker cited in FDA warning letter

Three Japanese drugmakers have been cited in FDA warning letters in recent months.

For the third time in recent months, the FDA has slammed a Japanese drug company in a warning letter, this time for not doing enough to prevent contamination during aseptic filling.  

The most recent FDA missive was targeted at a sterile drug production facility in Tokyo operated by Sato Pharmaceutical. In a warning letter sent only days ago and posted Tuesday, the FDA criticized the drug facility over deficiencies in monitoring in the aseptic area, saying its directions are unclear for what monitors should do when yields fall outside action and alert limits.

It also dinged the drugmaker for not performing routine surface sampling in the cleanroom and found shortcomings with its air quality monitoring.


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The agency said it would be a good idea if Sato Pharmaceutical would get an outside consultant who could help it establish and maintain the standards expected by the FDA.

Last month the FDA issued a warning letter to Sato Yakuhin Kogyo, a solid-dose finished drugmaker in Kashihara City in Japan which was cited for serious data integrity issues. In that case, the Japanese company was found retesting batches that had failed a first test, then deleting data for those initial tests without explanation. It said the company didn’t bother to get to the root cause of the out-of-spec results.

And in the fall, the FDA issued a warning letter to Nippon Fine Chemical, saying the drugmaker had obstructed an FDA inspection at its plant. At the time, the FDA placed the company on its Import Alert list, which effectively banned its products from entering the U.S., although it does not appear on the FDA's most recent import alert list.

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