GE Healthcare AS, Lindesnes Site – FDA 483, Feb 7, 2025
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.
ID · d716c89a-6298-4894-b72b-4ce720d284b1
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.