Aid United International Co. Limited – FDA Warning Letter, Sep 29, 2010

On September 27-29, 2010, an FDA inspection of AID United International Co. Limited in Yangzhou City, China, revealed that their Class I medical devices, including adhesive bandages and first aid kits, are adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 352(t)(2) for failing to provide required information.

Key violations include: 1. **Complaint Files (21 CFR 820.198(a)):** Failure to maintain adequate complaint files and procedures, specifically not documenting shipping complaints and lacking provisions for Medical Device Report (MDR) evaluation. 2. **Environmental Control (21 CFR 820.70(c)):** Inadequate procedures for controlling environmental conditions in the environmentally controlled room, including undefined room classification, lack of particulate testing, and undefined testing frequency. 3. **Equipment Calibration (21 CFR 820.72(c)):** Failure to maintain adequate procedures and records for routine calibration of equipment, specifically for temperature gauges on ovens used for microbiological testing. 4. **Device Master Record (DMR) (21 CFR 820.181):** Failure to maintain an