# FDA WARNING_LETTER - Proandre SL - June 14, 2018

Source: https://www.keypedia.com/records/warning_letter/proandre-sl/37ab5cc8-71e7-4995-a7db-f646cbb1efc0

> FDA WARNING_LETTER for Proandre SL on June 14, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Proandre SL
- Inspection Date: 2018-06-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Proandre SL's drug manufacturing facility in Granollers, Barcelona, from June 11-14, 2018, identifying significant CGMP violations, rendering their drug products adulterated. Additionally, Proandre Antibacterial Soap Liquid and Proandre Hand Sanitizer Liquid are misbranded.

Violations include:
1.  **Lack of Finished Product Testing:** Failure to test drug products for identity and strength before release (21 CFR 211.165(a)). The firm only tested for specific gravity, pH, refraction, and microbiology. The response was inadequate, lacking a timeline for future testing and a plan for testing distributed retain samples.
2.  **Inadequate Stability Program:** Failure to follow a written stability testing program (21 CFR 211.166(a)). Stability testing time points were not adhered to, and the revised procedure did not include identity and strength testing at each time point.
3.  **Incomplete Batch Records:** Batch production and control records lacked complete information, showing white-out, unintelligible data, missing information (e.g., density, approval dates), overwrites without signatures/dates/explanations, and unverified laboratory test results (21 CFR 211.188).

The FDA noted inadequate data integrity and quality systems, strongly recommending a qualified consultant. Required actions include a comprehensive investigation into data inaccuracies, a risk

## Related Officers

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

Company: https://www.keypedia.com/companies/proandre-sl/c1977574-4752-4b59-9cb1-1d1065ac98bb

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