Home / Inspections / 844374

844374

SigmaPharm Laboratories LLC — FEI 3005444934

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 13, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Bensalem, PA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1297588 (VAI Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200965 (NAI Mon Feb 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158426 (NAI Tue Dec 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056891 (NAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015810 (VAI Mon Jun 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
672821 CFR 314.80(b)Failure to review ADE information
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report