FDA 483 - GE Healthcare AS, Lindesnes Site - February 07, 2025
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GE HealthCare, an API manufacturer in Lindesnes, Norway, received a Form 483 with three observations. The inspection revealed inadequate deviation investigations and CAPA actions for recurring endotoxin contamination in API intermediates. Additionally, the firm lacked appropriate controls to prevent drug substance contamination, including insufficient dust collector filtration and unprotected product containers, and failed to conduct annual product quality reviews within established timelines.
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