HanChuan FuMo Plastics Co., Ltd. – FDA Warning Letter, Jan 14, 2015

On May 13, 2015, the FDA issued a Warning Letter to HanChuan FuMo Plastics Co., Ltd. following an inspection from January 12-14, 2015, which found their non-surgical isolation gowns to be adulterated and misbranded.

The inspection revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). Key QS violations included: 1. Failure to establish and maintain procedures for purchasing control (21 CFR 820.50), specifically regarding supplier evaluation and re-auditing. 2. Failure to establish and maintain procedures for incoming product acceptance (21 CFR 820.80(b)), with the firm not following its sampling plan. 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100), lacking requirements for data analysis, verification of effectiveness, and information dissemination. 4. Failure to establish and maintain procedures for complaint handling (21 CFR 820.198(a)), specifically regarding MDR reportability evaluation, investigation necessity, and uniform processing. 5. Failure to establish quality audit procedures (21 CFR 820.22), not specifying audit elements, re-audit