FDA 483 - Fersinsa GB, SA de CV - September 23, 2022

An FDA inspection of Fersinsa Gb SA de CV in Ramos Arizpe, Coahuila, revealed significant deficiencies in their manufacturing processes for active pharmaceutical ingredients. Observations included inadequate equipment cleaning and validation, lack of procedures for foreign matter control, insufficient process validation for scale-down batches, and poor control over batch records. Additionally, the firm failed to maintain appropriate storage conditions for materials and did not follow proper inventory management (FIFO) practices.