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FDA Warns Japanese API Manufacturer

Posted 31 January 2018 | By Zachary Brennan 

FDA Warns Japanese API Manufacturer

The US Food and Drug Administration (FDA) this week released a warning letter sent to Okayama, Japan-based active pharmaceutical ingredient (API) manufacturer Daito Kasei Kogyo for releasing numerous drugs without completing the required testing, among other violations.

"You claimed that the drugs were tested for identity and assay, and met required specifications for these attributes. However, these tests were never conducted, so you had no assurance that the drugs conformed to specification. Your actions may have put consumers at risk," FDA said following a four-day inspection last July.

The warning letter notes that the firm told FDA that a former quality control (QC) manager "decided that identification tests would not be required if ‘…identification tests of raw materials were confirmed with COA [certificate of analysis] provided by the raw material manufacturers’ and that ‘The QC manager at the time approved the product without testing…’ Your revised SOP for issuing COA requires confirmation of raw data."

FDA, which placed the firm on import alert in October, also told it to hire a consultant.

Daito’s previous response to deficiencies found by FDA, according to the agency, was "inadequate because you have not shown how you intend to confirm such data, who is responsible for conducting tests, and how you intend to ensure the integrity of this data. You also failed to conduct a risk assessment on the effects of the lack of release testing on the quality of drugs you distributed."

Daito Kasei Kogyo Co Ltd 1/18/18


Categories: Regulatory News

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