Genlabs Corporation – FDA Warning Letter, Dec 9, 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.