FDA WARNING_LETTER - Proandre SL - June 14, 2018

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