583183

Addison Biological Laboratory Inc — FEI 3003624071

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 14, 2009
Fiscal Year
2009
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Fayette, MO (United States)

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
179121 CFR 211.80(c)Storage off Floor, Spaced Suitably
192221 CFR 211.166(a)(4)Testing in same container - closure system
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
241921 CFR 211.198(a)Complaint Handling Procedure
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures