483
Amgen Singapore Manufacturing Pte LtdFDA 483 - Amgen Singapore Manufacturing Pte Ltd - May 14, 2024
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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.
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