Eagle Parts and Products – FDA Warning Letter, Sep 16, 2008

On September 15-16, 2008, an FDA inspection of a powered wheelchair manufacturer in Augusta, GA, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure of Management Responsibility (21 CFR 820.20):** The firm lacked established quality policy/objectives, a designated management representative, and a documented quality plan. This was a repeat violation from a June 2006 inspection. 2. **Incomplete Quality Audit Procedures (21 CFR 820.22):** The Quality Audit procedure (SOP-007) only covered Device History Records, failing to ensure comprehensive quality system effectiveness. This was also a repeat violation. 3. **Failure to Document Non-conforming Product Disposition (21 CFR 820.90(b)):** Several Non-conforming Material Reports lacked documentation of disposition, justification for use, or authorization signatures for non-conforming parts. 4. **Failure to Investigate Nonconformities (21 CFR 820.100(a)(2)):** The firm failed to investigate the causes of numerous product and process nonconformities documented in the Medical Device Return Merchandise Authorization (RMA) Log. 5