770191

A-S Medication Solutions LLC — FEI 1450743

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 2, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Libertyville, IL (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
141121 CFR 211.105(b)Distinctive ID or code not recorded in batch record
150621 CFR 211.122(e)Destruction of obsolete labeling
194321 CFR 211.180(e)(1)Review of representative number of batches
197521 CFR 211.182Written records kept in individual logs
256921 CFR 211.198(b)Maintenance of Complaint File
262121 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
434021 CFR 211.142Written warehousing procedures established/followed
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up