FDA WARNING_LETTER - Sanitizer Supply LLC - March 31, 2022

The FDA issued a Warning Letter to Sanitizer Supply LLC following an inspection from March 24-31, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm released benzalkonium chloride-based (BZK) hand sanitizing wipes without performing potency and microbial testing, relying on an unstated method and lacking final product testing results. 2. **Inadequate component testing:** The firm failed to test incoming components and active ingredients (e.g., BZK) for identity, relying solely on unqualified suppliers' Certificates of Analysis (COA) without validating their reliability. 3. **Deficient Quality Control Unit (QCU):** The QCU failed to ensure CGMP compliance and product specifications. Issues included untrained Customer Service personnel handling complaints, a complaint procedure lacking review and severity classification requirements, and numerous missing QCU-related documents.

The firm stated it ceased manufacturing operations and engaged a consultant, but provided no specific corrective action evidence. The FDA acknowledged the cessation but noted the firm remains registered. If manufacturing resumes, the firm must implement adequate corrective actions, notify the FDA for a meeting, and engage a qualified consultant for a comprehensive CGMP audit. The firm is responsible for the quality of drugs produced as a contract facility. A written response detailing corrective actions is required within 1