Loading…
Phillips Precision, Inc., a contract manufacturer of orthopedic implants and instruments located in Elmwood Park, NJ, was found to produce adulterated medical devices that failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted from April 22 through July 17, 2024, identified critical violations including failure to adequately validate processes where results cannot be fully verified by subsequent inspection and testing, specifically related to their Master Validation Plan Process and Software Validation procedure (SOP-34) governing cleaning machine operations. The company's August 8, 2024 response to the FDA 483 observations was deemed insufficient to address the underlying compliance failures.