# FDA 483 - Microbiologics Inc - December 01, 2021

Source: https://www.keypedia.com/records/483/microbiologics-inc/22204646-379a-4a35-a79f-e97989d40afc

> FDA 483 for Microbiologics Inc on December 01, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microbiologics Inc
- Inspection Date: 2021-12-01
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/microbiologics-inc/1119e833-f482-493c-bdb6-2cbbfcb8f3a6)

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.keypedia.com/companies/microbiologics-inc/468a8404-40bd-4e42-bbee-edaa7ffece55

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d