Hubei Weikang Protective Products Co., Ltd. – FDA Warning Letter, Apr 4, 2013

On August 12, 2013, the FDA issued a Warning Letter to Hubei Weikang Protective Products Co., Ltd. following an inspection from April 1-4, 2013, which found their surgical masks to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's July 16, 2013, response to the FDA 483 was not reviewed due to late submission.

Violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** The CAPA procedure (WK/QR-0-13) was inadequate, lacking non-conformance data collection by (b)(4) and not requiring verification/validation of corrective actions. The firm's April 25, 2013, response was deemed inadequate as objective evidence of implementation and English translation of the CAPA procedure were not provided. 2. **Failure to establish and maintain design transfer procedures (21 CFR 820.30(h)):** No documentation of design transfer activities was provided. The firm's April 25, 2013, response was inadequate as the new SOP was still in development