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833734

GenPak Solutions LLC — FEI 3008815009

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
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))
  • 939392 (OAI Wed Aug 12 2015 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
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
197521 CFR 211.182Written records kept in individual logs