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986279

Formulation Technology LLC — FEI 2937960

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 23, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oakdale, CA (United States)

Facility

Other inspections at this facility

  • 1264439 (VAI Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1222833 (OAI Thu Nov 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114912 (VAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102717 (VAI Tue Sep 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840156 (VAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
189021 CFR 211.165(e)Test methods
361321 CFR 211.160(b)(4)Establishment of calibration procedures
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly