FDA 483 - Validation Systems Inc - April 13, 2017

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.