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FDA Inspection 1107981 — Amphastar Nanjing Pharmaceuticals Inc

Amphastar Nanjing Pharmaceuticals Inc — FEI 3009805706

The FDA completed an inspection of Amphastar Nanjing Pharmaceuticals Inc on October 11, 2019 in Nanjing. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 11, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nanjing (China)

Facility

Other inspections at this facility

  • 1269036 (NAI Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036696 (NAI Thu Oct 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969870 (NAI Fri Apr 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874298 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources