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, was inspected by the FDA. The inspection revealed two observations concerning inadequate disinfectant efficacy studies and deficiencies in procedures designed to prevent microbiological contamination of drug substances. These issues indicate a need for improved controls in environmental monitoring and material handling.
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