483
PCAS Finland OyPCAS Finland Oy – FDA 483, Jun 7, 2024
Record Details
An FDA inspection of PCAS Finland Oy, an API manufacturer in Turku, revealed significant deficiencies in quality control and facility maintenance. The firm failed to investigate unknown impurities detected by an in-house method and lacked established maintenance procedures for critical manufacturing equipment. Additionally, the inspection found poorly maintained manufacturing spaces and equipment in bioburden-controlled areas, including structural damage and compromised airflow.
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ID · a4cf5446-2b4b-4f84-8402-1c6b9c3beec3
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