FDA 483 - Intercos Europe S.p.A - March 15, 2024

An FDA inspection of Intercos Europe S.p.A, an OTC drug manufacturer in Agrate Brianza, Italy, revealed significant deficiencies in quality control and manufacturing practices. Observations included inadequate testing of components, lack of scientific justification for sampling methods, and incomplete investigations into microbiological excursions and batch record discrepancies. The firm also failed to maintain complete laboratory records and adequately document equipment cleaning procedures, with one observation being a repeat finding from a previous inspection.