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

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