4L Health Co., Ltd., Huizhou, China – FDA Inspections

Inspection records and compliance data for 4L Health Co., Ltd. in Huizhou. 2 FDA inspections on record, 1 Form 483, last inspected October 27, 2016.

Company Profile

This profile covers 4L Health Co., Ltd. based in Huizhou, China.

FDA Inspection History

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

First inspected June 20, 2013. Last inspected October 27, 2016.

Most cited issue areas

Design changes - Lack of or Inadequate Procedures1 inspection
Documentation1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
October 27, 2016	Not classified	Medical Devices & Rad Health · Compliance: Devices	1029851
June 20, 2013	VAI	Medical Devices & Rad Health · Compliance: Devices	840801

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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