FDA WARNING_LETTER - Ming Fai Industrial Co LTD - March 10, 2023

On June 1, 2023, the FDA issued a Warning Letter to Ming Fai Industrial Estate, following an inspection from March 6-10, 2023, in Shenzhen, China. The inspection revealed that the firm's ultrasound gel and probe cover products are adulterated under 21 U.S.C. § 351(h) because 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 adequately validate processes (21 CFR 820.75(a))**: The firm lacked documentation for the validation of Ethylene Oxide (EO) sterilization of probe cover kits, formulation calculation software for ultrasound gel, and cleaning of mixing tank equipment. The firm's March 23, 2023, response was deemed inadequate as it lacked evidence of procedure effectiveness, training documentation, specific IQ/OQ/PQ protocols/reports for software, CAPA tracking, and investigation documentation for equipment listing errors. 2. **Failure to identify product acceptance status (21 CFR 820.86)**: In-process and finished sterile products were co-located without clear identification of sterility status, relying on a single loose paper. The firm's response, proposing a new warehouse layout and revised procedure, was inadequate due to