CMP Industries, Llc – FDA Warning Letter, May 29, 2015

On April 16, 2015, through May 29, 2015, an FDA inspection of CMP Industries, LLC in Albany, NY, identified significant Quality System and Correction and Removal violations for their medical devices, Impak Elastic Acrylic Resin Liquid and Impak Repair Acrylic Resin. The devices were deemed adulterated under 21 U.S.C. § 351(h) for non-conformity with current good manufacturing practice requirements of 21 CFR Part 820.

Violations included: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: The firm did not implement design control procedures for Impak Repair Acrylic Resin Liquid, lacking documentation for design and development planning, inputs, outputs, review, verification, validation, transfer, and change activities. A design history file was not created or maintained. The firm's retrospective plan and partial design plan were deemed inadequate as they did not include review or revision of design control procedures.

2. **Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: CAPA procedures were inadequate, failing to ensure proper investigation of nonconformities, identify actions to prevent recurrence, and verify effectiveness. Specific issues with CAPA #69 included: * Failure to take corrective action for all affected