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628529

A-S Medication Solutions LLC — FEI 1450743

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 22, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Libertyville, IL (United States)

Facility

Other inspections at this facility

  • 1199213 (NAI Thu Feb 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172338 (NAI Wed Jun 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054512 (VAI Tue Jun 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031726 (NAI Mon Oct 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834331 (VAI Wed May 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
163221 CFR 211.130(c)Lot or control number assigned
202621 CFR 211.192Quality control unit review of records
241921 CFR 211.198(a)Complaint Handling Procedure
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
363221 CFR 211.170(b)Annual visual exams of drug products
434121 CFR 211.142(a)Quarantine - written procedures
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
436021 CFR 211.170(b)Reserve drug product sample quantity - all tests