Home / Inspections / 1232979

1232979

K.W. Griffen Company — FEI 1211177

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 15, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Norwalk, CT (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1270809 (VAI Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062093 (VAI Tue Aug 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 771859 (VAI Tue Feb 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698666 (VAI Thu Nov 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 630664 (NAI Mon Nov 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683021 CFR 314.80(c)(2)Interval
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
684221 CFR 314.80(j)Failure to maintain records
891221 CFR 314.81(b)(2)Timely submission