# FDA EIR - Laboratorios Farmaceuticos Rovi S. A. - May 19, 2023

Source: https://www.keypedia.com/records/eir/laboratorios-farmaceuticos-rovi-s-a/5e8af247-f953-4e24-b14f-e83faf6e54f7

> FDA EIR for Laboratorios Farmaceuticos Rovi S. A. on May 19, 2023. 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: 2023-05-19
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Laboratorios Farmaceuticos Rovi S.A. in Spain was conducted from May 11 to May 19, 2023, to assess compliance with Good Manufacturing Practices. The inspection revealed several critical deficiencies. Inspectors found that key manufacturing steps, such as the filling process for excipients and active pharmaceutical ingredients, lacked formal written procedures, and operator training for these activities was undocumented. This raised concerns about process control and consistency.

Another significant issue involved product quality control. The company was observed to be excluding rejected vials with embedded particles from quality calculations without adequately validating the visual inspection method for identifying these particles or providing documented training to inspectors for this specific process. This practice questioned the reliability of quality data and product release decisions. Furthermore, the inspection noted problems with analytical method validation and stability studies, specifically regarding peak purity analysis and insufficiently justified mass balance discrepancies in stress studies.

Following the inspection, Laboratorios Farmaceuticos Rovi S.A. was issued a six-item FDA-483 (Inspectional Observations). Company management acknowledged the findings, committed to evaluating and correcting the identified deficiencies, and stated they would submit a written response to the FDA within 15 business days. The firm also reported initiating Corrective and Preventive Actions (CAPAs) to address some observations.

## Related Documents

- [EIR - 2022-06-27](https://www.keypedia.com/records/eir/laboratorios-farmaceuticos-rovi-s-a/48fd99be-0daa-4c70-8509-b3af701170ee)
- [483 - 2022-06-27](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/1ae6f9ba-c43c-471c-ac33-2f9ba5a38f6e)
- [483 - 2022-06-27](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/8851ad65-4451-4aa1-9146-182dc5e121d1)
- [483 - 2023-05-19](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/de6b1c49-ee55-4d1c-98a1-4ac36ada1bb1)
- [483 - 2023-05-19](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/67c4f0e5-e0be-4912-a16a-a4050435a895)

## Related Officers

- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c