FDA 483 - Micro Distributing I I, Ltd - March 07, 2023

During an inspection, Micro Distributing I I, Ltd in Belton, TX, was cited for significant deficiencies in its quality system. The firm failed to establish written procedures for handling customer complaints and did not develop, maintain, or implement written Medical Device Reporting (MDR) procedures. These issues indicate a lack of robust processes for post-market surveillance and regulatory compliance.