# FDA 483 - Laboratorios Farmaceuticos Rovi S.A. - June 29, 2022

Source: https://www.globalkeysolutions.net/records/483/laboratorios-farmaceuticos-rovi-sa/c56c8e0a-34bb-4118-b3b4-f299ee48bb51

> FDA 483 for Laboratorios Farmaceuticos Rovi S.A. on June 29, 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: 2022-06-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laboratorios Farmaceuticos Rovi S.A.'s chemical and physical testing laboratory in Alcala De Henares, Madrid, Spain, revealed significant deficiencies. The firm's quality control unit failed to follow written procedures for out-of-specification investigations, maintain data integrity, and control laboratory documentation. Additionally, the inspection found inadequate performance qualification procedures and execution for critical laboratory equipment.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/laboratorios-farmaceuticos-rovi-sa/9569550c-92c0-4f97-9d86-aaa00d5ec2e0)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/laboratorios-farmaceuticos-rovi-sa/019c3ba5-bcaf-470a-891f-cbb963660262

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