# FDA 483 - Quali Controle - September 15, 2017

Source: https://www.globalkeysolutions.net/records/483/quali-controle/7eb331d3-1868-499e-be64-a9a921eb8b79

> FDA 483 for Quali Controle on September 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quali Controle
- Inspection Date: 2017-09-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Qual-Controle & Qual-Controle-C.E.Bac, a control testing laboratory in Meru, France, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate investigations of out-of-specification results, a lack of quality assurance oversight in laboratory operations, and unvalidated test methods. The firm also failed to implement proper computer system controls and unjustifiably extended reagent expiration dates.

## Related Documents

- [WARNING_LETTER - 2017-09-15](https://www.globalkeysolutions.net/records/warning_letter/quali-controle/22d533ce-769a-4efa-838e-f8237d86e69c)
- [483 - 2024-12-13](https://www.globalkeysolutions.net/records/483/quali-controle/c30227c9-bfa7-4f4f-a084-8f51db6a5e8c)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/djamila-harouaka/106cef03-a214-4184-963a-6580d3bd7fd9)

Company: https://www.globalkeysolutions.net/companies/quali-controle/19b64d1b-0417-43f9-ae30-317539756145

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321