FDA Inspection 795779 — 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 August 17, 2012 in Littleton, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Littleton, NH (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
191221 CFR 211.166(a)Written program not followed
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
440021 CFR 211.186(b)(8)Description of containers, labels, et. al.