# FDA WARNING_LETTER - BR SAS - September 22, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/br-sas/9d1e5fb3-2a0a-4d55-8c44-8468e44e8ff1

> FDA WARNING_LETTER for BR SAS on September 22, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BR SAS
- Inspection Date: 2017-09-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Biologique Recherche (B.R.) SAS following a September 18-22, 2017, inspection of their Suresnes, France drug manufacturing facility, citing significant CGMP violations. The FDA found the firm's drug products adulterated due to non-conforming manufacturing methods, facilities, or controls. The company's October 13, 2017, response was deemed inadequate.

Key violations include:
1.  **Failure to test drug products:** The firm released OTC drug products without adequate testing for identity and strength of active ingredients (21 CFR 211.165(a)).
2.  **Failure to test components:** Incoming raw materials were not tested for identity, purity, or strength; the firm relied on unqualified supplier COAs (21 CFR 211.84(d)(1) and (2)).
3.  **Inadequate quality control unit procedures:** The firm lacked written procedures for numerous quality unit functions, including deviation investigations, annual product reviews, OOS results, and batch record management (21 CFR 211.22(d)).
4.  **Inadequate stability testing:** The firm lacked sufficient stability data to demonstrate drug product quality throughout their expiry (21 CFR 211.166(a)).
5.  **Unvalidated manufacturing processes:** Production processes were not

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/br-sas/df3ca2ca-af1a-4ab8-baab-59a4c8ffbc6e

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c