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1156395

Ascend Laboratories, LLC — FEI 3004459274

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Bedminster, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1144680 (VAI Thu Jun 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023638 (NAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856772 (VAI Wed Dec 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709952 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (274) (Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • Seizure (423707) (Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission