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1232512

Appco Pharma LLC — FEI 3010014758

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Piscataway, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1216223 (VAI Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179037 (VAI Fri Aug 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122406 (NAI Fri Mar 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093238 (NAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071495 (VAI Tue Nov 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673521 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events