483
Celgene International SarlFDA 483 - Celgene International Sarl - September 15, 2017
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Celgene International Sarl in Boudry, Switzerland, was inspected by the FDA from September 11-15, 2017. The inspection revealed a significant deficiency in control procedures for monitoring manufacturing processes, specifically regarding in-process and start-up checks for tablet and capsule production. This indicates a lack of adequate quality control to detect variability in drug product characteristics.
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ID · dd34c9b9-bfdc-40a4-90f4-a52e2dfe161b