FDA WARNING_LETTER - Xiantao Rayxin Medical Products Co. Ltd. - July 04, 2012

On October 5, 2012, the FDA issued a Warning Letter to Xiantao Rayxin Medical Products Co. Ltd. following a July 2-4, 2012, inspection of their surgical mask manufacturing facility in Xiantao City, China. The FDA determined that the firm's surgical masks are adulterated as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(b))**: The firm's CAPA procedure was not implemented. Issues like lack of design control procedures and a design history file (DHF) were identified but not captured in the CAPA system. Method changes from CAPA were not documented in procedures or checklists, and verification/validation activities for a CAPA were ineffective. 2. **Failure to establish and maintain adequate design verification procedures (21 CFR 820.30(f))**: The design control procedure lacked methods for design verification, and the verification report for model 1530 face masks did not demonstrate output meeting input requirements. 3. **Failure to establish and maintain adequate design validation procedures (21 CFR 820.30(g))**: The design control procedure