FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

German Drugmaker Rapped for Recordkeeping Issues

Sept. 5, 2018

The FDA hit German drug and API manufacturer Boehringer Ingelheim with a Form 483 for recordkeeping shortcomings at its Ingelheim am Rhein facility.

The company’s records did not include a complete inventory of sealed product containers filled with finished drug product, as it did not account for manually rejected containers removed from the production line by operators.

Batch production records also lacked secondary documentation in the form of a direct supervisor’s signature in order to verify critical manufacturing steps involved in the production of API intermediates.

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