FDA 483 - Microbiologics Inc - December 01, 2021

An FDA inspection of Microbiologics Inc. in Saint Cloud, MN, revealed significant compliance issues, including the failure to report multiple Class II device recalls involving products with shelf-life failures or contamination. Additionally, the firm lacked established process control procedures and proper documentation for the manufacture of SARS-CoV-2 process control devices, indicating a risk to product quality and patient safety.