St. Louis-based API man­u­fac­tur­er slammed with FDA warn­ing let­ter over 'per­va­sive mold,' qual­i­ty is­sues

The growth of API man­u­fac­tur­ing in In­dia and Chi­na has led to nu­mer­ous warn­ing let­ters and lots of ques­tion marks around qual­i­ty con­trol and da­ta in­tegri­ty is­sues. But vi­o­la­tions by US-based API man­u­fac­tur­ers can be just as ques­tion­able.

For in­stance, in a warn­ing let­ter dat­ed last week, St. Louis-based API man­u­fac­tur­er Jost Chem­i­cal was cri­tiqued for the way it failed to ad­e­quate­ly re­spond to mold con­t­a­m­i­na­tion, fol­low­ing com­plaints from Au­gust 2018 re­lat­ed to its man­u­fac­ture of potas­si­um sul­fate.

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