1067364

Airgas USA, LLC — FEI 2250062

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 28, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cherry Hill, NJ (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
177721 CFR 211.150(b)Distribution Recall System
188321 CFR 211.165(a)Testing and release for distribution
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202721 CFR 211.192Investigations of discrepancies, failures
361121 CFR 211.160(b)(3)Acceptance of drug products
439121 CFR 211.180(e)(2)Items to cover on annual reviews