FDA Inspection 599326 — Tender Corporation D/B/A Adventure Ready Brands

Tender Corporation D/B/A Adventure Ready Brands — FEI 1250045

The FDA completed an inspection of Tender Corporation D/B/A Adventure Ready Brands on July 1, 2009 in Littleton, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.

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