Mission Pharmacal CompanySeptember 22, 2022

FDA 483 - Mission Pharmacal Company - September 22, 2022

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Record Details

Mission Pharmacal Company in Boerne, TX, a drug product manufacturer, received two observations during an FDA inspection. The facility was cited for inadequate pest control, with live insects and glue boards found in a drug product coating room. Additionally, the firm failed to maintain written records and conduct investigations for unexplained discrepancies, specifically regarding a pinhole leak in manufacturing equipment.

Company: Mission Pharmacal Company
Inspection Date: September 22, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
Person: Michelle A. Krayer

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ID · c1fa42f1-b5d4-43b9-a7ab-c65cbe41084c