Amgen Singapore Manufacturing Pte. Ltd.
Form 483 issued May 14, 2024 · Singapore, Singapore
- Inspection
- May 6 – May 14, 2024
- Investigator
- Liqun Zhao
- Observations
- 2
- Pages
- 2
- FEI number
- 3011255424
In short: On May 14, 2024, FDA issued a Form 483 with 2 observations to Amgen Singapore Manufacturing Pte. Ltd. in Singapore, Singapore (FEI 3011255424) after an inspection that ran May 6 – May 14, 2024. The investigator was Liqun Zhao. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm did not conduct a disinfectant efficacy study (DES) based on environmental isolates and materials…
- 02
Procedures designed to prevent microbiological contamination of drug substances…
This inspection in context
Liqun Zhao
4 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ireland.
The firmAmgen Singapore Manufacturing Pte. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Singapore Manufacturing Pte. Ltd.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Amgen Singapore Manufacturing Pte. Ltd.?
Liqun Zhao is named on this Form 483, for the inspection of May 6 – May 14, 2024. Each investigator has a profile showing what they cite most.
When was Amgen Singapore Manufacturing Pte. Ltd. inspected by FDA?
The inspection ran May 6 – May 14, 2024, and the Form 483 is dated May 14, 2024.
How do I get the full Form 483 for Amgen Singapore Manufacturing Pte. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.