# FDA 483 - ACS Dobfar SPA (Plant #2) - July 18, 2017

Source: https://www.globalkeysolutions.net/records/483/acs-dobfar-spa-plant-2/a19a3f04-faa5-44c2-865a-35dc99cfd880

> FDA 483 for ACS Dobfar SPA (Plant #2) on July 18, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACS Dobfar SPA (Plant #2)
- Inspection Date: 2017-07-18
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of ACS Dobfar s.p.a. (Plant #2) in Milan, Italy, revealed significant deficiencies in their drug manufacturing processes. Observations included a lack of adequate process validation for drug products, insufficient controls to prevent cross-contamination, and failures in procedures designed to prevent microbiological contamination of sterile drug products. These issues indicate a high potential for product quality and safety concerns.

## Related Officers

- [Samina S. Khan](https://www.globalkeysolutions.net/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/acs-dobfar-spa-plant-2/334c9ae3-385e-4162-a53a-d53e34111e29

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