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1144680

Ascend Laboratories, LLC — FEI 3004459274

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bedminster, NJ (United States)

Facility

Other inspections at this facility

  • 1156395 (VAI Wed Nov 10 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures