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1230475

Chartwell Pharmaceuticals Congers, LLC — FEI 3008897678

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Congers, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1277530 (OAI Tue Nov 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206056 (VAI Wed May 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068395 (VAI Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992472 (VAI Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885844 (NAI Mon Jun 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
683021 CFR 314.80(c)(2)Interval
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission