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FDA Inspection
•Amgen Singapore Manufacturing Pte Ltd•January 29, 2019

Amgen Singapore Manufacturing Pte Ltd – FDA Inspection, Jan 29, 2019

Record Details

This FDA Inspection record concerns Amgen Singapore Manufacturing Pte Ltd, with an inspection on January 29, 2019, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Amgen Singapore Manufacturing Pte Ltd
Inspection Date
January 29, 2019
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Zhihao Pete Qiu (Issuing Officer)
View Company Profile

ID · 66272d25-6097-4632-9426-c931264f8f6a

Inspection Facts

Inspection number
1079136
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Amgen Singapore Manufacturing Pte Ltd

5
DateClassificationOfficeProject area
May 14, 2024Not classifiedOffice of Inspections and Investigations
October 25, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 18, 2019Not classifiedOffice of Inspections and Investigations
May 25, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 27, 2017Not classifiedOffice of Inspections and Investigations
Other documents for Amgen Singapore Manufacturing Pte Ltd
  • FDA Inspection 1244897 - 2024-05-14
  • FDA Inspection 1112149 - 2019-10-25
  • FDA Inspection 1082474 - 2019-01-18
  • FDA Inspection 1060510 - 2018-05-25
  • FDA Inspection 998776 - 2017-01-27

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