FDA 483 - Procos S.p.A.

Procos S.p.A., an Active Pharmaceutical Ingredient manufacturer in Cameri, Italy, was cited for significant deficiencies during an FDA inspection. Observations included a lack of formal validation for water used in manufacturing and solvent recovery processes, as well as inadequate procedures for handling out-of-specification stability sample conditions. These issues highlight concerns with quality control and adherence to good manufacturing practices.