Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistMing Fai Industrial Co LTD, a manufacturer of ultrasound gel and probe cover products in Shenzhen, China, failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The company did not adequately validate critical manufacturing processes, specifically failing to maintain documentation validating Ethylene Oxide (EO) sterilization for its probe cover kit—instead relying on validation data from a different device (C-Arm Drape) packaged in similar materials. This adulteration violation was identified during an FDA inspection conducted March 6-10, 2023, and the company's March 23, 2023 response was deemed inadequate to address the inspectional observations.