Home / Inspections / 612055

612055

Romark Laboratories, L.C. — FEI 3003966280

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2009
Fiscal Year
2009
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))
  • 1010173 (VAI Mon May 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 806976 (NAI Tue Nov 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
682921 CFR 314.80(c)(2)Failure to report non-alert ADEs
683021 CFR 314.80(c)(2)Interval