# FDA WARNING_LETTER - Quali Controle - September 15, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/quali-controle/22d533ce-769a-4efa-838e-f8237d86e69c

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

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Quali Controle
- Inspection Date: 2017-09-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Quali-Controle & Quali-Controle C.E.BAC following a September 2017 inspection, citing significant violations of CGMP regulations for testing finished pharmaceuticals, rendering their drugs adulterated.

Key violations include:
1.  **Failure to validate test methods (21 CFR 211.165(e))**: The firm used unvalidated non-compendial test methods for drug product analysis. Their response, which included adding a disclaimer to Certificates of Analysis, was deemed inadequate as it did not address reviewing past analyses or ensuring future method validation/transfer. The FDA requires a protocol and timelines for method validation/transfer, an assessment of the impact of unvalidated methods on U.S. market products, and a procedure for future method validation.
2.  **Failure to investigate OOS results (21 CFR 211.192)**: The firm invalidated out-of-specification (OOS) results without scientific justification or a documented investigation. Their claim of dirty glassware as a root cause lacked scientific basis and adequate CAPA. The FDA requires a retrospective review of OOS results, a report of findings, a CAPA plan, and a revised OOS investigation procedure.
3.  **Failure to follow Quality Agreement**: The firm did not adhere to their quality agreement with a customer regarding the use of the United States Pharmacopeia for drug component testing and failed

## Related Documents

- [483 - 2017-09-15](https://www.globalkeysolutions.net/records/483/quali-controle/7eb331d3-1868-499e-be64-a9a921eb8b79)
- [483 - 2024-12-13](https://www.globalkeysolutions.net/records/483/quali-controle/c30227c9-bfa7-4f4f-a084-8f51db6a5e8c)

## Related Officers

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

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

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