TALON, an S & S Technology Company – FDA Warning Letter, Mar 28, 2019

On August 2, 2019, the FDA issued a Warning Letter to TALON, an S&S Technology Company, following an inspection from March 11-28, 2019. The inspection revealed that TALON, a manufacturer of Class I & II medical devices, had adulterated devices due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to document CAPA activities and results (21 CFR 820.100(b))**: CAPAs were closed without verifying corrective actions, e.g., for internal audit effectiveness, risk analysis completion, and updated job descriptions. 2. **Failure to establish design change procedures (21 CFR 820.30(i))**: Design changes were implemented without documented verification or validation, specifically for the Class II VAC-FIX System. 3. **Failure to control nonconforming product (21 CFR 820.90(a))**: Procedures lacked requirements for evaluating nonconformances and initiating investigations, a repeat observation from 2011. 4. **Failure to maintain device history records (21 CFR 820.184)**: No batch records or lot/batch numbers for sub-components, and approximately 1,000 Class II VAC-FIX Systems lacked UDI numbers or production