611879

HNC Products Inc. — FEI 3000205427

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clinton, IL (United States)

Citations

IDCFRDescription
150521 CFR 211.122(d)Label storage access limited to authorized personnel
362321 CFR 211.170(a)Active ingredient retained sample kept
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
438921 CFR 211.198(a)Procedures to be written and followed
900121 CFR 211.22(a)Lack of quality control unit