FDA EIR - Medichem, S.A. - April 30, 2015

An FDA Good Manufacturing Practice (GMP) inspection was conducted at Medichem, S.A. in Celra, Spain, from April 27 to April 30, 2015. This comprehensive inspection focused on a bulk Active Pharmaceutical Ingredient (API) manufacturer, guided by Compliance Program 7356.002F (Active Pharmaceutical Ingredient Process Inspections) and ICH Q7A guidelines. The inspection covered key systems including quality, facilities and equipment, materials, packaging and labeling, and laboratory operations. Significantly, the inspection concluded with no observations of non-compliance. Consequently, Medichem, S.A. was not issued an FDA-483 form, indicating an absence of regulatory violations. While no formal regulatory actions were mandated, the firm proactively agreed to modify its Standard Operating Procedure for periodic product reviews to ensure products with fewer than three batches are reviewed at least quarterly. The report reflects a facility operating with robust quality systems and adherence to regulatory standards.