ChemRite CoPac LLC – FDA Warning Letter, Jul 15, 2016

The FDA issued a Warning Letter to ChemRite CoPac, Inc. following an inspection from June 6 to July 15, 2016, which found significant CGMP violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Separate Areas (21 CFR 211.42(c)):** The firm manufactures OTC oral drug products using the same equipment as toxic non-pharmaceutical industrial products (e.g., car care products, leather treatments). This poses a high risk of contamination due to the difficulty of removing industrial product ingredients from shared equipment. The FDA requires the firm to discontinue manufacturing drugs on shared equipment or provide a plan for dedicated manufacturing areas, and conduct a risk assessment for all previously produced drugs on shared equipment, including potential recalls. 2. **Insufficient Laboratory Testing (21 CFR 211.165(b)):** The firm released at least 24 batches of an OTC drug product between 2013 and 2015 without performing required microbiological testing for *Pseudomonas aeruginosa*, despite batch records reporting its absence. The contract lab's raw data showed no such analysis. The firm's response, citing customer-obtained results, was deemed inadequate. The FDA demands an investigation into this failure, root cause analysis, a timeline for retain testing, and a retrospective review of all released lots for complete microbiological testing. 3. **In