FDA 483 - Pharmacia & Upjohn Company LLC - December 10, 2018

This FDA Form 483 was issued to Pharmacia & Upjohn Company, LLC, identifying significant deficiencies in their quality system for medical devices, specifically Gelfoam and Gelfilm products. Repeat observations highlight systemic issues with corrective and preventive actions, process validation, and complaint handling. The firm failed to adequately establish procedures for CAPA effectiveness checks, validate packaging processes, control seal integrity testing, conduct quality audits against 21 CFR 820, submit timely MDRs, and calibrate equipment.