FDA 483 - PROSANA DISTRIBUCIONES SA DE CV - March 09, 2017

An FDA inspection of PROSANA DISTRIBUCIONES SA DE CV, an OTC drug manufacturer in Mexico, revealed significant deficiencies in its quality system. The firm lacked essential written procedures, process validation, and quality control oversight for its Bicaruvas Antiacid Efervescent Powder, raising concerns about product identity, strength, quality, and purity. Key issues included inadequate batch records, raw material controls, equipment cleaning procedures, yield calculations, labeling controls, stability data, and employee training.