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

Source: https://www.keypedia.com/records/eir/laboratorios-farmaceuticos-rovi-s-a/48fd99be-0daa-4c70-8509-b3af701170ee

> FDA EIR 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: EIR
- Company Name: Laboratorios Farmaceuticos Rovi S. A.
- Inspection Date: 2022-06-27
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection was conducted at Laboratorios Farmaceuticos Rovi S. A. in Madrid, Spain, from June 16 to June 27, 2022. The inspection focused on several critical areas related to pharmaceutical manufacturing and quality control, assessing compliance with regulatory standards. Investigators reviewed the firm's method validation processes, including reports and electronic test data for assay and related substances. This encompassed scrutiny of test methodology, instruments, materials, validation results, system suitability, linearity, accuracy, precision, and robustness, confirming that all applicable methods were stability indicating. No issues were noted in this area. The inspection also included an evaluation of sampling and testing procedures, with a walkthrough of the microbiological laboratory, observing endotoxin testing and media preparation. Again, no issues were observed during this review. Furthermore, the management of outsourced activities and purchased materials was assessed. This involved reviewing the firm's documentation for subcontractors and confirming the proper oversight of manufacturing and testing performed by other Rovi entities. The firm's vendor qualification procedure, "Management of Suppliers and Services," which details assessment of vendors for GMP compliance, was also reviewed. In both outsourced activities and supplier management, no discrepancies were noted by the inspectors. Overall, for the reviewed sections of the FDA inspection, Laboratorios Farmaceuticos Rovi S. A. demonstrated satisfactory adherence to regulatory expectations, with no violations or required actions identified in the areas of method validation, sampling and testing, outsourced activities, or supplier management.

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## Related Officers

- [Arsen Kanapetyan](https://www.keypedia.com/people/arsen-kanapetyan/e0df99e3-40b8-47fe-9d97-834473743965)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64