# FDA 483 - Laboratorios Farmaceuticos Rovi S. A. - May 19, 2023

Source: https://www.keypedia.com/records/483/laboratorios-farmaceuticos-rovi-s-a/67c4f0e5-e0be-4912-a16a-a4050435a895

> FDA 483 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: 483
- Company Name: Laboratorios Farmaceuticos Rovi S. A.
- Inspection Date: 2023-05-19
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: On May 19, 2023, the FDA issued a Form 483 to Laboratorios Farmaceuticos Rovi S. A., a sterile drug manufacturer in Madrid, Spain, following an inspection from May 11-19, 2023. The inspection revealed six observations related to quality system and manufacturing issues.

**Observation 1:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, and followed. This includes continued use of gloves with pinholes, lack of procedures and documented training for a specific filling tool, inadequate storage and disinfection of sterilized equipment, and untracked rejects during aseptic filling. Additionally, integrity testing data for gloves is not reviewed, printed, or retained.

**Observation 2:** Procedures for preventing microbiological contamination lack adequate validation of aseptic and sterilization processes. Media fills are not representative of routine production regarding critical interventions, fill length, and maximum personnel. Non-viable monitoring excursions are not always investigated, and sterilization cycle validations for equipment and isolators are inadequate, with biological indicators not placed in worst-case positions. Smoke studies also fail to demonstrate unidirectional airflow for all activities.

**Observation 3:** Control procedures for monitoring and validating manufacturing processes, particularly visual inspection of aseptically filled products, are not established. There is no procedure for inspecting embedded particles in stoppers, and particles found in commercial batches are not identified. Visual inspector qualification is inadequate, with test kits not representative of all

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8