Devices

8 Observations in Phillips Precision Inspection

A 4/22-7/17/2024 FDA inspection at Phillips Precision in Elmwood Park, NJ, found Quality System Regulation violations in the firm’s contract manufacturing of orthopedic implants and instruments. A just-released 12/9/2024 Warning Letter says specific violations were:

failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures;
failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications when deviations from device specifications could occur as a result of the manufacturing process;
failure to adequately establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
failure to adequately establish and maintain procedures for implementing corrective and preventive action;
failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product;
failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities;
failure to adequately establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met; and
failure to adequately establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

Phillips was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome