FDA WARNING_LETTER - Indy E Cigs LLC - March 26, 2019

On March 26, 2019, the FDA issued a Warning Letter to an unnamed entity located at 5797 Park Plaza Ct, Indianapolis, IN 46220. This letter followed an inspection conducted from October 29 to November 9, 2018. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, specifically 21 CFR Part 211.

The primary violations cited were: 1. **Failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet specifications** (21 CFR 211.192). The firm failed to adequately investigate out-of-specification (OOS) results for drug products, including a sterility OOS for a sterile injectable product. The investigation into the sterility failure was deemed insufficient, lacking a thorough root cause analysis and failing to extend to other potentially affected batches. 2. **Failure to establish and follow written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess** (21 CFR 211.100(a)). The firm lacked adequate process validation for its sterile injectable drug products, specifically regarding aseptic processing. The media fill program was found deficient, with an insufficient