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939392

GenPak Solutions LLC — FEI 3008815009

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 12, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Hilliard, OH (United States)

Facility

Other inspections at this facility

  • 1014779 (VAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833734 (VAI Fri May 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 740965 (NAI Tue Aug 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
176721 CFR 211.137(a)Expiration date lacking