# FDA 483 - Laboratorios Farmaceuticos Rovi S. A. - June 27, 2022

Source: https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/1ae6f9ba-c43c-471c-ac33-2f9ba5a38f6e

> FDA 483 for Laboratorios Farmaceuticos Rovi S. A. on June 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Farmaceuticos Rovi S. A.
- Inspection Date: 2022-06-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laboratorios Farmaceuticos Rovi S. A. in Madrid, Spain, revealed significant deficiencies in sterile drug manufacturing. The firm failed to adequately investigate unexplained discrepancies and out-of-specification results, did not follow procedures to prevent microbiological contamination, and used equipment not of appropriate design. Additionally, the quality control unit's responsibilities were not fully followed, particularly regarding the review of contract manufacturer data, indicating serious concerns for product quality and safety.

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## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/laboratorios-farmaceuticos-rovi-s-a/3712d05f-4680-4715-a671-621575ab3ea7

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