Amigo Mobility International, Inc – FDA Warning Letter, Jan 15, 2010

On May 21, 2010, the FDA issued a Warning Letter to Amigo Mobility International, Inc. following an inspection from December 16, 2009, to January 15, 2010, at their Bridgeport, Michigan facility. The inspection revealed that the firm's devices, including the Amigo Escort 7.5, Amigo RD, and Amigo RT Express, were adulterated under 21 U.S.C. 351(h) 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 control design (21 CFR 820.30):** No design control procedures or documented activities for the devices. 2. **Inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100):** The existing CAPA procedure was not comprehensive and had never been initiated or used. 3. **Failure to control nonconforming product (21 CFR 820.90(a)):** Nonconformance Reports lacked determination or rationale for investigation. 4. **Inadequate complaint procedures (21 CFR 820.198(a)):** No documented complaints since November 20