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700497

Applied Laboratories, Inc. — FEI 1831301

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Columbus, IN (United States)

Facility

Other inspections at this facility

  • 1048476 (VAI Tue Apr 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016674 (VAI Wed Jun 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 914551 (VAI Fri Feb 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868494 (VAI Tue Feb 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 762117 (VAI Mon Jan 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116321 CFR 211.28(b)Habits of good sanitation & health
191221 CFR 211.166(a)Written program not followed
241921 CFR 211.198(a)Complaint Handling Procedure
358321 CFR 211.110(a)Written in-process control procedures