MED&CARE (SHENZHEN) CO., LTD., Shenzhen, China – FDA Inspections

Inspection records and compliance data for MED&CARE (SHENZHEN) CO., LTD. in Shenzhen. 2 FDA inspections on record, 1 Form 483, last inspected December 08, 2016.

Company Profile

This profile covers MED&CARE (SHENZHEN) CO., LTD. based in Shenzhen, China.

FDA Inspection History

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

First inspected April 2, 2014. Last inspected December 8, 2016.

Most cited issue areas

Design validation - user needs and intended uses1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
December 8, 2016	Not classified	Medical Devices & Rad Health · Compliance: Devices	1022376
April 2, 2014	NAI	Medical Devices & Rad Health · Compliance: Devices	874846

FDA documents

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

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