# FDA 483 - Rovi Pharma Industrial Services S.A. - September 22, 2023

Source: https://www.keypedia.com/records/483/rovi-pharma-industrial-services-sa/0b00ccfd-3835-4820-9340-11290629e3e4

> FDA 483 for Rovi Pharma Industrial Services S.A. on September 22, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rovi Pharma Industrial Services S.A.
- Inspection Date: 2023-09-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: During an FDA inspection, two observations were made regarding the facility's operations.

**Observation 1** details a failure to thoroughly review unexplained discrepancies and out-of-specification results.
*   **A.** CAPA SC-160/23 was opened due to Procedure PNTSR035 lacking a timeframe for reading environmental monitoring plates after incubation. From February to March 2023, some plate results were not read and recorded for up to 21 days post-incubation. While the CAPA addresses amending the procedure, associated deviations (e.g., S0102/23-DV) and CAPAs do not include an analysis of all affected plate results or their impact.
*   **B.** On April 22, 2023, an aberrant result was obtained for a sample point. Investigation report IR-20011/1 noted that this sample was run multiple times due to failing %RSD suitability requirements, exceeding the procedure's permitted attempts without elevating the event to an investigation.

**Observation 2** concerns deficient procedures for equipment cleaning and maintenance, specifically regarding the protection of clean equipment from contamination. The logbook for material receipt and removal from "Introduccion de Materiales a Zona Clasificada D la Planta (SR049F0I)" requires a hold time for materials sanitized with (bY{-4 before moving to the Classified D zone. From June

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## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/rovi-pharma-industrial-services-sa/947a0616-87f8-4886-a6c2-278c5e678192

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7