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993082

Vertical Pharmaceuticals, LLC — FEI 3004421212

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 1, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Sayreville, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1222553 (NAI Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106926 (NAI Wed Sep 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059217 (VAI Wed Jul 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 704957 (VAI Mon Dec 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 646066 (OAI Wed Feb 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
672821 CFR 314.80(b)Failure to review ADE information
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683021 CFR 314.80(c)(2)Interval
891221 CFR 314.81(b)(2)Timely submission