1218305

International Trading Pharm Lab Inc — FEI 1000208853

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 21, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Paterson, NJ (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
440621 CFR 211.194(a)(2)Suitability of testing methods verified