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1251315

Leading Pharma, LLC — FEI 3001611969

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fairfield, NJ (United States)

Facility

Other inspections at this facility

  • 1129205 (NAI Tue Aug 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079111 (VAI Thu Jan 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067964 (NAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010916 (VAI Fri Apr 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965261 (VAI Thu Mar 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
359221 CFR 211.110(c)In-process materials characteristics testing