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710017

Guardian Drug Co. Inc. — FEI 2245306

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 18, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dayton, NJ (United States)

Facility

Other inspections at this facility

  • 1304382 (NAI Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231141 (NAI Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1162476 (VAI Thu Feb 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030766 (VAI Mon Nov 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890734 (NAI Fri Aug 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
191421 CFR 211.166(a)Lack of written stability program
360321 CFR 211.160(b)Scientifically sound laboratory controls
363921 CFR 211.204Returned drug procedures in writing and followed