FDA 483 - Colgin, Inc - September 21, 2023

Colgin, Inc., a drug manufacturer in Dallas, TX, was cited for significant deficiencies in its quality control unit, manufacturing processes, and facility maintenance during an FDA inspection. The firm failed to follow written procedures, validate processes, test raw materials and finished products, and used expired ingredients, indicating a severe lack of cGMP adherence. The facility also showed poor sanitation and equipment maintenance.