# FDA 483 - Holodiag - March 23, 2022

Source: https://www.globalkeysolutions.net/records/483/holodiag/a49bb05a-fea3-4702-ae24-937a8e65393f

> FDA 483 for Holodiag on March 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Holodiag
- Inspection Date: 2022-03-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Holodiag, a contract testing laboratory in Val de Reuil, France, was cited for three observations during an FDA inspection. The findings indicate significant deficiencies in data integrity, specifically regarding computer system controls and audit trails, as well as inadequate written procedures for complaint handling and employee cGMP training within the quality control unit. These issues highlight a lack of robust quality system controls.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/holodiag/f1de9b13-0444-4268-b734-8903e288c3c5

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