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1059714

Andapharm, LLC — FEI 3005000348

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 18, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Lauderdale, FL (United States)

Facility

Other inspections at this facility

  • 961715 (VAI Fri Feb 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 764765 (VAI Tue Feb 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 602314 (VAI Fri Aug 07 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
191421 CFR 211.166(a)Lack of written stability program