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FDAnews Drug Daily Bulletin

Two API Makers Land 483s for Deficient Procedural Systems

July 18, 2016

Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities.

Drugmakers Delavau and Faencal Tartaric both were cited for deficiencies in setting and following proper manufacturing procedures to ensure batch conformity, according to a pair of Form 483s.

Delavau’s Philadelphia-based facility landed a 10-observation 483 for its deficiencies, six of which were repeats of findings from an earlier inspection in 2013. Many of the complaints center on the company’s handling of its monitoring program.

The 483 cites a lack of recordkeeping on stability characteristics, storage conditions and retesting dates.

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