FDA 483 - American Performance Polymers, LLC - December 21, 2022

American Performance Polymers, LLC in Colebrook, NH, was cited with six observations during an FDA inspection. The firm failed to establish device master records, device history records, and procedures for acceptance activities and contamination prevention. Additionally, corrective and preventive actions and complaint files were inadequately maintained, indicating significant deficiencies in their quality system for manufacturing Class I medical devices.