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

Source: https://www.keypedia.com/records/483/amgen-singapore-manufacturing-pte-ltd/8c61c98f-33b1-439d-bafd-93ab14fca597

> 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: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2024-05-14](https://www.keypedia.com/records/483/amgen-singapore-manufacturing-pte-ltd/1e4020ac-cb02-443c-9f1c-e46fbcd4cb50)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Sudipan Karmakar](https://www.keypedia.com/people/sudipan-karmakar/3037fa5f-a982-4b25-ad94-df1c9e81c853)
- [Liqun Zhao](https://www.keypedia.com/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)
- [Biologist](https://www.keypedia.com/people/milos-dokmanovic/b6c79c1d-754a-46ab-977b-adc90cedcac2)

Company: https://www.keypedia.com/companies/amgen-singapore-manufacturing-pte-ltd/ff869a15-a7c2-441a-8165-7fd77928331e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8