# FDA 483 - Amgen Singapore Manufacturing Pte Ltd - May 14, 2024

Source: https://www.globalkeysolutions.net/records/483/amgen-singapore-manufacturing-pte-ltd/1e4020ac-cb02-443c-9f1c-e46fbcd4cb50

> FDA 483 for Amgen Singapore Manufacturing Pte Ltd on May 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amgen Singapore Manufacturing Pte Ltd
- Inspection Date: 2024-05-14
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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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Company: https://www.globalkeysolutions.net/companies/amgen-singapore-manufacturing-pte-ltd/ff869a15-a7c2-441a-8165-7fd77928331e

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321