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685512

Accord Healthcare, Inc. — FEI 3007518432

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 16, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Durham, NC (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1005516 (NAI Thu Jan 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859238 (NAI Fri Dec 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732127 (NAI Wed May 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports