# FDA 483 - Procos S.p.A. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/procos-spa/68c99ba1-b7da-4894-ae17-5782cd5c8e88

> FDA 483 for Procos S.p.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Procos S.p.A.
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: 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.

## Related Officers

- [Karyn M. Campbell](https://www.globalkeysolutions.net/people/karyn-m-campbell/d3d8df7e-1261-435a-bda9-f46dbdf1ef97)

Company: https://www.globalkeysolutions.net/companies/procos-spa/12d9ddf8-b522-4852-bb9f-8080101c547f

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4