Microbiologics IncDecember 1, 2021

FDA 483 - Microbiologics Inc - December 01, 2021

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Record Details

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.

Company: Microbiologics Inc
Inspection Date: December 1, 2021
Product Type: Device
Office: Minneapolis District Office
Person: Jennifer S. Ness (investigator)

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ID · 22204646-379a-4a35-a79f-e97989d40afc