FDA WARNING_LETTER - Phillips Precision, Inc. - July 17, 2024

On December 9, 2024, the FDA issued a Warning Letter to Ms. Jeanne M. Phillips following an inspection from April 22, 2024, to July 17, 2024, at their Elmwood Park, NJ facility, which contract manufactures orthopedic implants and instruments. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate the cleaning process for orthopedic implants and instruments, including insufficient challenge conditions during operational qualification (OQ) and performance qualification (PQ) of the cleaning machine. Issues included lack of cytotoxicity, endotoxin, and particulate testing during OQ, inadequate worst-case parameter challenging, undefined load configurations, and failure to conduct process validation for additional post-production cleaning methods. The firm also failed to adequately implement a Process Failure Modes and Effects Analysis (PFMEA) for the cleaning process, particularly regarding severity scores for final cleaning. 2. **Process Control Procedures (21 CFR 820.70(a)):** Failure to implement established cleaning procedures, specifically regarding co-mingling and stacking of products in cleaning loads. 3. **Monitoring and Control of