483
Amgen Singapore Manufacturing Pte LtdAmgen Singapore Manufacturing Pte Ltd – FDA 483, May 14, 2024
Record Details
AMGEN Singapore Manufacturing Pte. Ltd., a drug substance manufacturer in Singapore, received two observations during an FDA inspection. The firm failed to conduct a disinfectant efficacy study specific to its site's environmental isolates and materials. Additionally, procedures to prevent microbiological contamination of drug substances were not adequately established, including issues with plate reading time limits and inconsistent material disinfection practices.
View Company Profile
ID · 8c61c98f-33b1-439d-bafd-93ab14fca597
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.