American Medical Systems, Inc. – FDA Warning Letter, Feb 24, 2014

During an FDA inspection from February 4-24, 2014, American Medical Systems, Inc. (AMS) was found to be manufacturing adulterated devices, including the AMS 800 Urinary Control System and AMS 700 Series Inflatable Penile Prosthesis, due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate processes (21 CFR 820.75(a)):** Numerous manufacturing processes and test methods for the AMS 800, AMS 700, AdVance Male Sling System, Ambicor 2-Piece Inflatable Penile Implant, Spectra Non-Inflatable 1-Piece Implant, and Y-Mesh Sacral Colpopexy System were either not validated or inadequately validated. 2. **Failure to conduct adequate risk analysis (21 CFR 820.30(g)):** Action items from post-market surveillance reports for AMS 800 and AMS 700, such as updating design Failure Modes and Effects Criticality Analysis (dFMECA) to reflect actual complaint rates and updating risk management reports, were not completed or not completed within required timeframes. 3. **Failure to establish adequate corrective and preventive action (CAPA) procedures (2