599326

Tender Corporation — FEI 1250045

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 1, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Littleton, NH (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
172821 CFR 211.87Retest of approved components/containers/closures
188321 CFR 211.165(a)Testing and release for distribution
200821 CFR 211.186(a)Written procedures followed
355321 CFR 211.48(a)Plumbing System Defects
355521 CFR 211.48(b)Drains--Size, Back-siphonage Prevention
430321 CFR 211.67(b)Written procedures fail to include
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step