FDA 483 - Huvepharma Inc. - January 17, 2025

Huvepharma Inc., a drug manufacturer in Saint Louis, MO, was cited for three observations during an FDA inspection. The observations relate to inadequate master production records for lot and expiry codes, failure of the quality control unit to follow procedures during stability testing, and insufficient testing of components for harmful impurities. These issues indicate significant concerns regarding quality control and manufacturing process adherence.