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1238346

AstraZeneca Pharmaceuticals LP — FEI 1000198729

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gaithersburg, MD (United States)

Facility

Other inspections at this facility

  • 1254239 (NAI Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230136 (NAI Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1211604 (NAI Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1157291 (NAI Thu Sep 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136278 (NAI Fri Feb 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
241921 CFR 211.198(a)Complaint Handling Procedure