FDA 483 - Originitalia SRL - May 24, 2024

Originitalia SRL, a pharmaceutical manufacturer in Caldogno, Vicenza, Italy, received a Form 483 with seven observations highlighting significant deficiencies across its quality control, production, and equipment systems. The firm failed to perform adequate product testing, lacked a stability testing program, and maintained incomplete laboratory records. Additionally, issues included insufficient process validation, inaccurate production records, reliance on supplier COAs without identity testing, and a lack of equipment qualification and written non-conformance investigation procedures.