FDA 483 - Fagron, Inc - December 21, 2017

Fagron, Inc. in Saint Paul, MN, a manufacturer and API repacker, received 10 observations during an FDA inspection from November to December 2017. The firm demonstrated significant deficiencies across its quality, laboratory, packaging, labeling, materials, production, and facilities/equipment systems. Key issues included inadequate quality management, improper handling of out-of-specification results, insufficient GMP training, and poor control over labeling, rejected components, and equipment records.