# FDA 483 - Originitalia SRL - May 24, 2024

Source: https://www.keypedia.com/records/483/originitalia-srl/4716ba89-e6e0-4cb1-affe-26977e3857ed

> FDA 483 for Originitalia SRL on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Originitalia SRL
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2024-05-24](https://www.keypedia.com/records/warning_letter/originitalia-srl/f2fc077d-f7a6-4630-9202-3310da83bacc)

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/originitalia-srl/783d9c63-614a-4af2-9e91-d66f9031cc95

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1