# FDA WARNING_LETTER - Aid United International Co. Limited - September 29, 2010

Source: https://www.keypedia.com/records/warning_letter/aid-united-international-co-limited/58009ca4-8b09-47b1-b9cf-d0dc12eb18bb

> FDA WARNING_LETTER for Aid United International Co. Limited on September 29, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Aid United International Co. Limited
- Inspection Date: 2010-09-29
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Steven D. Smith](https://www.keypedia.com/people/steven-d-smith/f10ab464-cd57-47d7-82ec-571fd8be5a4a)

Company: https://www.keypedia.com/companies/aid-united-international-co-limited/41b8bcfd-b77b-4ff0-9feb-a272214628f3

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7