FDA WARNING_LETTER - Verde Cosmetic Labs, LLC - October 15, 2021

The FDA inspected Verde Cosmetic Labs LLC from September 27 to October 15, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Quality Control Unit Failure:** The Quality Unit (QU) failed to ensure drug products comply with CGMP and specifications. Products were released based on verbal microbiological results before final reports, and the firm's response regarding incompetent staff and recruitment was deemed inadequate without assessing impact on drug quality or ensuring new staff competency. 2. **Inadequate Production and Process Control Procedures:** The firm lacked adequate process validation for drug products, including pain-relief products, and failed to properly qualify filling line equipment. Their response was insufficient, lacking a risk assessment for distributed unvalidated products and details on prospective validation. 3. **Inadequate Cleaning and Maintenance Procedures:** The firm failed to demonstrate adequate cleaning procedures to prevent cross-contamination between drug and non-drug products on shared filling lines. Cleaning validation was inadequate, documentation of equipment cleaning was missing or incorrect, and the Purified Water (PW) system lacked documented sanitization. 4. **Failure to Document Laboratory Control Mechanisms:** The firm did not follow PW system procedures, including sampling and pressure gauge monitoring. Numerous Out-of-Specification (OOS) results for conductivity and total organic carbon were found and not investigated.

The FDA recommends engaging a qualified CGMP