FDA WARNING_LETTER - Shanghai Neo-Medical Import & Export Co., Ltd. - July 22, 2015

On November 2, 2015, the FDA issued a Warning Letter to Shanghai Neo-Medical Import & Export Co., Ltd. following an inspection from July 20-22, 2015. The inspection revealed that the firm's surgical masks 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 furnish required information under 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for analyzing quality data, documenting verification/validation of actions, and submitting CAPAs for management review. The firm's response was inadequate, lacking revision timelines, plans for evaluating past CAPAs, and personnel training. 2. **Failure to establish and maintain complaint file procedures (21 CFR 820.198(a))**: The "Customer Complaint and Feedback Control System" did not require timely complaint evaluation for MDR reporting or maintenance of complete investigation records. The response was inadequate, lacking revision timelines, plans for evaluating past complaints, and personnel training. 3