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FDA Inspection
•Amgen Manufacturing Ltd•May 8, 2019

Amgen Manufacturing Ltd – FDA Inspection, May 8, 2019

Record Details

This FDA Inspection record concerns Amgen Manufacturing Ltd, with an inspection on May 8, 2019, issued by the San Juan District Office, covering human drugs.

Company
Amgen Manufacturing Ltd
Inspection Date
May 8, 2019
Product Type
Human Drugs
Office
San Juan District Office
Person
  • Maxwell L. Van Tassell (Issuing Officer)
View Company Profile

ID · e1972aa3-6bf7-409e-bc6b-6a62651684a7

Inspection Facts

Inspection number
1093715
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Amgen Manufacturing Ltd

19
DateClassificationOfficeProject area
April 27, 2026Not classifiedSan Juan District Office
July 5, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 27, 2019VAISan Juan District OfficeNew Drug Evaluation
April 11, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 6, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 19 other inspections on the company page
Other documents for Amgen Manufacturing Ltd
  • FDA Inspection 1294400 - 2026-04-27
  • FDA Inspection 1209484 - 2023-07-05
  • FDA Inspection 1105967 - 2019-09-27
  • FDA Inspection 1085900 - 2019-04-11
  • FDA Inspection 1061201 - 2018-08-06

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