FDA WARNING_LETTER - Azurity Pharmaceuticals, Inc. - March 02, 2023

The FDA inspected Azurity Pharmaceuticals, Inc. (FEI 3003395329) at 841 Woburn Street, Wilmington, MA, from February 2, 2023, to March 2, 2023. The inspection and subsequent website review revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The firm manufactures unapproved new drug products, including FIRST® Lansoprazole, FIRST® Pantoprazole, FIRST® Metronidazole, and FIRST® Mouthwash BLM, which are prohibited from interstate commerce under sections 301(d) and 505(a) of the FD&C Act because they lack FDA-approved applications.

Additionally, significant Current Good Manufacturing Practice (CGMP) violations were identified, rendering the drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Violations include: 1. Failure to thoroughly investigate unexplained discrepancies or failures of batches or components to meet specifications (21 CFR 211.192). The firm's investigations into unexplained discrepancies were inadequate, failing to identify root causes or implement effective CAPAs. 2. Failure to establish and follow an adequate written testing program for stability characteristics and to use results to determine storage conditions and expiration dates (21 CFR 211.166(a)). The firm