483
PCAS Finland OyFDA 483 - PCAS Finland Oy - September 13, 2019
Record Details
PCAS Finland Oy, a manufacturer in Turku, Finland, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning procedures for equipment, deficient equipment qualifications failing to ensure proper performance, and insufficient certification records for classified production areas. These issues indicate a lack of control over manufacturing processes and environmental conditions.
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ID · 7b834bfa-b546-48d8-8742-08c28c804e1d