1034103

A&Z Pharmaceutical Inc — FEI 1000521505

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 22, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
208621 CFR 211.208Salvaging and return to marketplace
363221 CFR 211.170(b)Annual visual exams of drug products
434021 CFR 211.142Written warehousing procedures established/followed