P.M.T. Corp – FDA Warning Letter, Aug 4, 2009

On July 22-August 4, 2009, an FDA inspection of PMT Corporation, a manufacturer of medical devices including breast expanders and neurosurgical electrodes, revealed violations of the Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations cited in the FDA 483 included: 1. **Failure to adequately validate processes (21 CFR 820.75(a))**: Specifically, sterilization process validation issues such as improper biological indicator placement and failure to evaluate load variations. Also, Depthalon Electrode In-Line Interconnection System testing failed acceptance criteria without required design mitigation and retesting. 2. **Failure to adequately document justification for nonconforming product use (21 CFR 820.90(b)(1))**: A positive biological indicator for a sterile load resulted in some devices being re-sterilized, but others from the same load were released without re-sterilization or justification. 3. **Failure to analyze quality data (21 CFR 820.100(a)(1))**: Non-conforming product and rework data were not included in failure mode quality trending. 4. **Failure to perform complete risk analysis (21 CFR 820.30(