1110927

Tender Corporation — FEI 1250045

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 25, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Littleton, NH (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
180921 CFR 211.160(a)Following/documenting laboratory controls
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls