918332

Lloyd Inc. of Iowa — FEI 1911196

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 20, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Shenandoah, IA (United States)

Citations

IDCFRDescription
139521 CFR 211.103Actual vs. theoretical yields not determined
189021 CFR 211.165(e)Test methods
192021 CFR 211.166(a)(3)Valid stability test methods
203121 CFR 211.194(a)Complete test data included in records
241921 CFR 211.198(a)Complaint Handling Procedure
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431621 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
434921 CFR 211.160(b)(2)In-process samples representative, identified properly
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action