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Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) — FDA Facility Profile

FEI 3010728912

Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) is an FDA-registered facility (FEI 3010728912) located in Zhejiang 325025, CN. Registered operations: API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Zhejiang 325025 (CN)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

Recent inspections

  • 1261674 (NAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084107 (VAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981968 (VAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866095 (NAI Fri Dec 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 582495 (VAI Thu Apr 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • DP4-0641535-7/1/1 (Thu Sep 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • N05-0202799-3/1/1 (Tue Jul 11 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources