Azurity Pharmaceuticals, Inc. Warning Letter Details

Summary

Azurity Pharmaceuticals manufactured unapproved drug products under the FIRST® Unit-of-Use Kit line (including Lansoprazole, Pantoprazole, Metronidazole, and Mouthwash BLM) without required FDA approval, violating sections 301(d) and 505(a) of the FD&C Act. An FDA inspection of the Wilmington, Massachusetts facility from February to March 2023 identified significant Current Good Manufacturing Practice (CGMP) violations in the company's methods, facilities, and controls for manufacturing, processing, packing, and holding finished pharmaceuticals, rendering the products adulterated under section 501(a)(2)(B) of the FD&C Act. The company's website labeling for these products made therapeutic claims indicating intended drug use without corresponding FDA approval.