483
Validation Systems IncValidation Systems Inc – FDA 483, Apr 13, 2017
Record Details
Validation Systems Inc, a contract laboratory in Palo Alto, CA, was cited for significant deficiencies across multiple quality system areas. The inspection revealed inadequate environmental monitoring in aseptic processing, a failure to investigate unexplained discrepancies, and issues with cleaning procedures, microbiological contamination prevention, and adherence to production controls. The firm also demonstrated a lack of quality unit oversight in component approval.
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ID · d9b48a2a-e4e7-45e9-b71f-6b6f3872bbf3
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