FDA WARNING_LETTER - Byd Precision Manufacture Co., Ltd - May 26, 2023

On September 5, 2023, the FDA issued a Warning Letter to Baolong Industrial following an inspection from May 22-26, 2023, which found their BYD Surgical Mask Models FE2111, FE2311B, and BYD N95 Respirator Model DE2322 to be adulterated and misbranded.

The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30), specifically lacking procedures for surgical N95 respirator model DE2322 and surgical mask models FE2311 and FE2311B. 2. Failure to validate processes where results cannot be fully verified by subsequent inspections and tests, and failure to document validation activities (21 CFR 820.75(a)). Equipment numbers in validation documents did not match manufacturing equipment, and not all manufacturing equipment units had validation documents. 3. Failure to maintain Device Master Records (DMRs) (21 CFR 820.181) for surgical N95 respirator model DE2322 and surgical masks, despite only model DE2