610869

Continental Manufacturing Chemist, Inc. — FEI 1910648

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 17, 2009
Fiscal Year
2009
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Madrid, IA (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
189121 CFR 211.165(f)Failing drug products not rejected
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs