FDA WARNING_LETTER - Seatex, LLC - October 20, 2023

The FDA issued a Warning Letter to Seatex, LLC, following an inspection from October 16-20, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The company's November 3, 2023, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm used the same equipment for OTC hand sanitizers and non-pharmaceutical industrial chemicals, risking cross-contamination. No cleaning validation studies were provided. Corrective actions require a comprehensive retrospective assessment of cleaning effectiveness, a CAPA plan for operations oversight, and remediation of cleaning processes. 2. **Failure to Investigate Discrepancies (21 CFR 211.192):** The firm did not adequately investigate out-of-specification (OOS) results, retesting until a passing result was obtained without scientific justification, and failed to record or retain OOS results. Required actions include a complete assessment of documentation systems, a retrospective independent review of invalidated OOS results for the last three years, and a comprehensive remediation plan for OOS investigation systems. 3. **Failure to Test Components and Validate Supplier Analyses (21 CFR 211.84(d)(1) and 21