Phillips Precision, Inc.

Warning LetterOpen

Jeanne M. Phillips Owner and CEO Phillips Precision, Inc. 7 Paul Kohner Pl Elmwood Park , NJ 07407 United StatesFEI 3003387384Issued Dec 9, 2024Center for Devices and Radiological Health

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Violations10

Issue DateDec 9, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Phillips Precision, Inc.
Location: Jeanne M. Phillips Owner and CEO Phillips Precision, Inc. 7 Paul Kohner Pl Elmwood Park , NJ 07407 United States
FEI Number: 3003387384
Country: United States
Issue Date: December 09, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Phillips Precision, Inc. FDA Warning Letter, December 9, 2024