Bentley Laboratories LLCAugust 17, 2022

FDA 483 - Bentley Laboratories LLC - August 17, 2022

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Record Details

Bentley Laboratories LLC in Edison, NJ, was cited with three observations during an FDA inspection concerning its manufacturing of OTC drug products. The firm failed to establish adequate control procedures and conduct process validation studies, and its batch production records lacked essential details and personnel identification. Additionally, sampling and testing plans for drug products were not properly described in written procedures.

Company: Bentley Laboratories LLC
Inspection Date: August 17, 2022
Product Type: Drugs
Office: New Jersey District Office
People: Monika Borkowska (investigator)
Anthony J. Donato (investigator)

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ID · 5701b218-4963-4f93-a32e-294c20c11436