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1010173

Romark Laboratories, L.C. — FEI 3003966280

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 8, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Tampa, FL (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1216528 (NAI Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 806976 (NAI Tue Nov 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 612055 (VAI Mon Sep 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

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