FDA WARNING_LETTER - Acme Monaco Corporation - March 07, 2014

On April 28, 2014, the FDA issued a Warning Letter to Acme Monaco Corporation following an inspection from February 18 to March 7, 2014. The inspection revealed that the firm's medical guidewires for cardiovascular and urologic use were adulterated as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The violations included: 1. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: Specifically, PTFE coated guidewires were not validated under actual or simulated use conditions, and risk analysis was inadequate regarding coating flaking and delamination. The firm ceased supplying post-coated PTFE guidewires but must assess the risk of products already on the market and provide design control procedures and an adequate risk analysis. 2. **Failure to establish and maintain procedures for design change control (21 CFR 820.30(i))**: The firm lacked procedures for controlling changes to PTFE coating formulation, which occurred without evaluation, validation, verification, review, or approval. Documentation of these procedures is required. 3. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: * Corrective actions for complaint #6240 (PTFE coating flaking)