Company

China

Jianerkang Medical Co., Ltd, Changzhou, China – FDA Inspections

Inspection records and compliance data for Jianerkang Medical Co., Ltd in Changzhou. 8 FDA inspections on record (1 OAI), 2 Form 483s, last inspected May 22, 2025.

Company Profile

This profile covers Jianerkang Medical Co., Ltd based in Changzhou, China.

FDA Inspection History

FDA inspections: 8
OAI: 1
VAI: 4
NAI: 2
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected September 19, 2011. Last inspected May 22, 2025.

Most cited issue areas

Cleaning / Sanitizing / Maintenance2 inspections
Buildings1 inspection
Buildings not maintained in good state of repair1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
May 22, 2025	NAI	Medical Devices & Rad Health · Compliance: Devices	1273963
November 22, 2024	Not classified	Human Drugs	1257611
November 1, 2019	VAI	Human Drugs · Drug Quality Assurance	1109765
March 9, 2018	VAI	Human Drugs · Drug Quality Assurance	1046965
August 26, 2016	NAI	Human Drugs · Drug Quality Assurance	995775
April 14, 2016	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	986623
April 2, 2014	VAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	880522
September 19, 2011	OAI	Human Drugs · Drug Quality Assurance	748707

FDA documents

Form 483s (1)

Form 483s · November 1, 2019

People (1)

Launner Rulon-Torres, CSO

Person

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