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FDA Inspection
•Amphastar Nanjing Pharmaceuticals Inc•April 28, 2017

Amphastar Nanjing Pharmaceuticals Inc – FDA Inspection, Apr 28, 2017

Record Details

This FDA Inspection record concerns Amphastar Nanjing Pharmaceuticals Inc, with an inspection on April 28, 2017, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Amphastar Nanjing Pharmaceuticals Inc
Inspection Date
April 28, 2017
Product Type
Human Drugs
Office
Office of Inspections and Investigations
People
  • Christopher T. Middendorf (FDA Associated Person)
  • Krishna Ghosh (Issuing Officer)
View Company Profile

ID · 4fc6bd5e-2e76-4169-ba5f-13b6dada7297

Inspection Facts

Inspection number
1017547
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Amphastar Nanjing Pharmaceuticals Inc

6
DateClassificationOfficeProject area
September 19, 2025Not classifiedOffice of Inspections and Investigations
March 7, 2025Not classifiedOffice of Inspections and Investigations
October 11, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 26, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 29, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for Amphastar Nanjing Pharmaceuticals Inc
  • FDA Inspection 1291882 - 2025-09-19
  • FDA Inspection 1269036 - 2025-03-07
  • FDA Inspection 1107981 - 2019-10-11
  • FDA Inspection 1036696 - 2017-10-26
  • FDA Inspection 969870 - 2016-04-29

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