Rovi Pharma Industrial Services S.A.September 22, 2023

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

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Record Details

Rovi Pharma Industrial Services S.a. in San Sebastian De Los Reyes, Madrid, a sterile manufacturer, received a Form 483 with two observations. The inspection revealed significant issues with quality control, specifically regarding the thorough review of unexplained discrepancies and out-of-specification results. Additionally, the firm's procedures for cleaning and maintaining equipment were found to be deficient, leading to potential contamination risks.

Company: Rovi Pharma Industrial Services S.A.
Inspection Date: September 22, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Dorothy P. Kramer
Jennifer Lalama

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ID · ab532f82-eab3-438d-aa11-e196f4456e70