727375

Mericon Industries Inc. — FEI 1450054

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Peoria, IL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
178721 CFR 211.80(a)Procedures To Be in Writing
181021 CFR 211.160(a)Lab controls established, including changes
192021 CFR 211.166(a)(3)Valid stability test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls
430621 CFR 211.80(a)Written Procedures Not Followed
437521 CFR 211.188(b)(5)In-process and laboratory control results
439121 CFR 211.180(e)(2)Items to cover on annual reviews