# FDA 483 - Procos S.p.A. - February 22, 2016

Source: https://www.keypedia.com/records/483/procos-spa/39e3202b-b59d-45ea-962b-2a7975f98f97

> FDA 483 for Procos S.p.A. on February 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Procos S.p.A.
- Inspection Date: 2016-02-22
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: During an inspection of Procos S.p.A., a pharmaceutical API manufacturer in Cameri, Italy, the FDA observed significant deficiencies in computerized system controls. The firm failed to maintain data integrity on its Empower-3 system, with audit trails disabled for numerous project folders and unauthorized deletion of HPLC projects. These issues raise concerns about the reliability of data used for product release and stability studies.

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/procos-spa/1766d7fc-a42b-4073-b2fe-ab188ccd08ab

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321