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1107845

International Trading Pharm Lab Inc — FEI 1000208853

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 29, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Paterson, NJ (United States)

Facility

Other inspections at this facility

  • 1218305 (OAI Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153840 (OAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972377 (VAI Fri Apr 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 832537 (NAI Tue May 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782998 (NAI Wed May 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
440621 CFR 211.194(a)(2)Suitability of testing methods verified