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846761

SpecGx LLC — FEI 1317295

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hobart, NY (United States)

Facility

Other inspections at this facility

  • 1122931 (NAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049694 (NAI Fri Apr 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 957282 (VAI Fri Jan 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777958 (VAI Fri Apr 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 646935 (VAI Wed Jan 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
144821 CFR 211.111Establishment of time limitations
357021 CFR 211.100(a)Approval and review of procedures