FDA WARNING_LETTER - Chem-Tech, Ltd. - September 20, 2024

The FDA inspected Chem-Tech, Ltd. from September 17-20, 2024, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated. The firm's October 11, 2024, response to the FDA 483 was deemed inadequate due to insufficient supportive documentation and evidence of corrective actions.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate out-of-specification (OOS) results for their (b)(4) OTC drug product, lacking root cause determination and CAPA. The firm also lacked scientifically supported mixing process validation and finished product hold time studies, with evidence of extended hold times without additional testing. 2. **Equipment Maintenance and Sanitation (21 CFR 211.67(a) and (b)):** Failure to clean, maintain, and sanitize equipment at appropriate intervals. The mixing tank and filling lines were in an unclean area with dirt, a dead insect, pooled drug product, and discoloration. There was no validated cleaning procedure or preventive maintenance program, and a water meter was uncalibrated. 3. **Inadequate Quality Control Unit Procedures (21 CFR 211.22(d)):** The quality unit lacked procedures for GMP training, handling OOS results, and change management. Procedures for deviations and complaints were inadequate