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1233334

KVK Tech, Inc. — FEI 3005117563

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Newtown, PA (United States)

Facility

Other inspections at this facility

  • 1229759 (NAI Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175552 (OAI Fri Jul 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086467 (OAI Tue Apr 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066940 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016049 (VAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
189021 CFR 211.165(e)Test methods
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications