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1140286

Bora Pharmaceuticals Injectables Inc — FEI 1000512361

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 16, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Baltimore, MD (United States)

Facility

Other inspections at this facility

  • 1236852 (NAI Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215798 (VAI Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1162959 (OAI Fri Feb 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091850 (NAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056814 (VAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
185121 CFR 211.84(e)Rejecting When Specifications Not Met
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures