Ei LLC – FDA Warning Letter, Oct 6, 2017

The FDA issued a Warning Letter to Product Quest MFG, LLC following an inspection of their drug manufacturing facility, Ei LLC, from October 2-6, 2017. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Separate Defined Areas (21 CFR 211.42(c)):** The firm manufactured human drugs and pesticides in the same building using shared equipment, leading to cross-contamination. Records confirmed two human drugs contained a pesticide. The FDA requires a plan for dedicated equipment and an analysis of pesticide testing results in other human drugs, including a risk assessment for all drugs previously produced on shared equipment, and plans for addressing product quality and patient safety risks for products still in distribution. 2. **Failure to Establish Adequate Cleaning Procedures (21 CFR 211.67(b)):** The firm did not adequately validate cleaning procedures to prevent cross-contamination between human drugs or between human drugs and non-pharmaceutical products. The FDA requires a comprehensive risk evaluation for all products manufactured and a detailed plan for adequate cleaning validation, including summary reports and analytical methods. 3. **Failure to Thoroughly Investigate Discrepancies (21 CFR 211.192):** Investigations into equipment cleaning and product contamination were not thorough or timely. An investigation into an unknown impurity in erythromycin