FDA WARNING_LETTER - NuGeneration Technologies LLC - September 22, 2022

The FDA inspected NuGeneration Technologies LLC.'s drug manufacturing facility in Emeryville, California, from September 14 to September 22, 2022, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, their drug products are deemed adulterated. The company's October 12, 2022, response to the FDA 483 was inadequate.

Key violations include: 1. **Failure to conduct adequate release testing:** The firm did not perform full release testing, including identity and strength of active ingredients (e.g., ethanol), impurity, and microbiological testing, for NuRinse Hand Sanitizer. 2. **Inadequate component testing:** The firm failed to test incoming active pharmaceutical ingredients (APIs) like ethanol and other components such as deionized (DI) water for identity, purity, strength, and quality. They relied on unqualified supplier Certificates of Analysis (COAs) for ethanol and did not test for methanol. The DI water system lacked sufficient testing for total organic carbon, microbial organisms, and accurate conductivity results. 3. **Lack of stability program:** The firm lacked stability data to support expiration dates for NuRinse Hand Sanitizer, failing to establish an adequate written testing program to assess stability characteristics. 4. **Failure to validate manufacturing process:** The firm did not validate