FDA 483 - Originitalia SRL - May 24, 2024
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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.
ID · 4716ba89-e6e0-4cb1-affe-26977e3857ed