FDA WARNING_LETTER - Sombra Cosmetics, Inc - July 26, 2024

The FDA inspected Sombra Cosmetics, Inc. from July 15-26, 2024, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's August 16, 2024, response was deemed inadequate due to insufficient documentation and evidence of corrective actions.

Key violations include: 1. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** * **Water System Deficiencies:** Failure to adequately demonstrate water suitability for manufacturing and cleaning, including inadequate TOC and conductivity testing, and microbial samples showing "TNTC" Gram-negative rods without further identification. The remediation plan lacked detail and timelines. * **Inadequate Process Validation:** Insufficient data to validate manufacturing processes and qualify equipment. The provided sample validation lacked acceptance criteria and product specifications, and no timeline for validation was given. * **Required Actions:** Comprehensive independent remediation plan for water systems (validation reports, improvements, monitoring procedures, action/alert limits), detailed risk assessment for distributed products due to water issues, and a detailed summary of the validation program for product lifecycle, including PPQ timelines, protocols, and cleaning validation improvements.

2. **Failure to Test Components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** * Failure to