FDA warns API maker Daito Kasei Kogyo, bans some products

An API maker in Osaka, Japan, whose slogan is "Happiness, Awe and Surprise" has joined a growing list of Japanese drugmakers to be criticized by the FDA in warning letters. In this case, the agency was concerned enough to also ban products from the company’s Okayama plant from the U.S. until it makes changes to its manufacturing.

The Jan. 18, 2018, warning letter to Daito Kasei Kogyo followed an investigation at the Bizen, Okayama, plant in July that also set the stage for the FDA to ban the facility’s products. Daito Kasei Kogyo's animal and human drug products were placed on the FDA import alert list in October.

The reasoning as the FDA laid out in its warning letter was that the facility wasn’t meeting even minimal standards. First off, the FDA cited the facility for releasing its drugs without first testing ingredients for identity and assay, a slip that it says puts "consumers at risk" for taking ineffective drugs and from possible exposure to toxic impurities.  

The company explained that the former quality-control manager at the plant said that testing wasn’t needed if "identification tests of raw materials were confirmed" by the certificate of authentication from raw material manufacturers.

The FDA explained that wasn’t good enough and that the plant was falsifying its own COAs sent to its customers by signing off on them without doing all the required tests. The FDA suggested Daito Kasei Kogyo hire a consultant if it intended to continue to sell products in the U.S.

The FDA cited a number of Japanese drugmakers last year, including the sterile drug plant in Tokyo operated by Sato Pharmaceutical. A warning letter criticized the 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.

Before that the FDA issued a warning letter to Sato Yakuhin Kogyo, a solid-dose finished drug maker 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.

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