FDA WARNING_LETTER - Genlabs Corporation - December 09, 2021

The FDA inspected Genlabs Corporation from November 29 to December 9, 2021, identifying significant CGMP violations, rendering drug products adulterated. The "FIRST STREET Dishwashing Concentrate & Antimicrobial Hand Soap" product was also deemed misbranded.

Key violations include: 1. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm uses the same equipment for drug and hazardous non-pharmaceutical products without adequate cleaning procedures, posing a cross-contamination risk. This is a repeat observation from 2017. The FDA requires a risk assessment for all affected drugs, a plan for manufacturing separation, and improvements to cleaning validation. 2. **Insufficient Laboratory Controls (21 CFR 211.165(a), (b), (e)):** Drug products were released without complete final testing, and analytical test methods lacked proper validation. This is a repeat observation. The FDA demands a list of specifications, a plan for testing retain samples, and an independent assessment of laboratory practices. 3. **Failure in Production and Process Control (21 CFR 211.100(a)):** The water system for drug manufacturing is unvalidated, and process validation for OTC drug products is lacking. This is a repeat observation. The FDA requires a comprehensive water system remediation plan, including testing for *Burkholderia cepacia complex*, and a detailed process validation program.