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Warning Letter

Case 592387 — FEI 3005117563

Facility

Recent inspections

  • 1233334 (OAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Action Details

Facility
KVK Tech, Inc.
Date
February 11, 2020
Fiscal Year
2020
Product Type
Drugs
Center
CDER
Location
Newtown, PA (United States)