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

Source: https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/8851ad65-4451-4aa1-9146-182dc5e121d1

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

---

## Details

- Record Type: 483
- Company Name: Laboratorios Farmaceuticos Rovi S. A.
- Inspection Date: 2022-06-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 document outlines several observations from an inspection of a facility involved in the commercial manufacturing of mg and mg Injection.

**Observation 1** details deficiencies in investigation procedures. Investigations into unexplained discrepancies and out-of-specification (OOS) results for the commercial manufacturing process, particularly concerning Human Machine Interface (HMI) performance issues, lacked conclusions and follow-up. Specifically, HMI "blocked" issues leading to filling operation stoppages (Deviations UDMI-NOT-22-120 and UDMI-INV-22-041) remained open, preventing observation of manufacturing. Additionally, OOS microbiology test results for packaging components (e.g., OOS No. QOS-MC-20-010 and OOS No. OOS-MC-20-020) lacked corrective/preventive actions (CAPAs) despite root cause determinations. The firm also failed to thoroughly review unexplained discrepancies, even for distributed batches.

**Observation 2** indicates that procedures to prevent microbiological contamination of sterile drug products were not followed. The aseptic filling process validation (UDMI-PMV-21-013/00, UDMI-IVP-22-010) was inadequate, as only 3 out of many production operators performed "corrective interventions" during process simulation, and these operators did not appear adequately qualified.

**Observation 3**

## Related Documents

- [483 - 2022-06-27](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/1ae6f9ba-c43c-471c-ac33-2f9ba5a38f6e)
- [483 - 2023-05-19](https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/034efd83-3e1c-428f-b224-d6977a83de39)
- [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

- [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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c