# FDA 483 - ROVI Pharma Industrial Services S.A. - April 22, 2016

Source: https://www.keypedia.com/records/483/rovi-pharma-industrial-services-sa/e5a19e77-46a1-4446-a679-44f27b28a9e3

> FDA 483 for ROVI Pharma Industrial Services S.A. on April 22, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ROVI Pharma Industrial Services S.A.
- Inspection Date: 2016-04-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Rovi Contract Manufacturing S.L. in Madrid, Spain, revealed significant deficiencies in aseptic processing and quality control systems. The firm failed to adequately monitor environmental conditions, ensure the efficacy of disinfectants, and investigate unexplained discrepancies such as low production yields for sterile drug products.

## Related Officers

- [Xiomara Copeland](https://www.keypedia.com/people/xiomara-copeland/274a596d-5625-47a0-8e38-877d03852c15)
- [Ademola O. Daramola](https://www.keypedia.com/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)

Company: https://www.keypedia.com/companies/rovi-pharma-industrial-services-sa/7358680b-374e-46ed-8afb-ff7040bcf1e4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8