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Jianerkang Medical Co., Ltd — FDA Facility Profile

FEI 3006403682

Jianerkang Medical Co., Ltd is an FDA-registered facility (FEI 3006403682) located in Changzhou City Jiangsu, CN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Changzhou City Jiangsu (CN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
both

Recent inspections

  • 1273963 (NAI Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1257611 (VAI Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109765 (VAI Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046965 (VAI Fri Mar 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995775 (NAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986623 (VAI Thu Apr 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880522 (VAI Wed Apr 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748707 (OAI Mon Sep 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • FY1-8037770-4/61/1 (Mon Apr 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 218-7004396-1/101/1 (Mon Oct 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 218-7004102-3/511/1 (Wed Jun 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HK8-0054048-4/4/1 (Fri Sep 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/2/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/3/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/6/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/5/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/4/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0001335-7/1/1 (Wed Jul 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources