# FDA 483 - Keybio - March 11, 2022

Source: https://www.keypedia.com/records/483/keybio/32da2ab1-9710-411f-8f62-7b059e4bff6b

> FDA 483 for Keybio on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keybio
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Keybio, a contract microbiology testing laboratory in La Ciotat, France, was cited for deficiencies in its laboratory controls and employee training. The inspection revealed a lack of written procedures for quantitative microbial enumeration and no periodic spot checks to verify the accuracy of colony counts. Additionally, the firm's training program for microbial testing technicians failed to assess their accuracy in determining viable microbial colonies.

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/keybio/fd9aa9a5-8a1c-4342-9026-73d4dbca6c97

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1