Cobes Industries (Hefei) Co., Ltd., Hefei, China – FDA Inspections

Inspection records and compliance data for Cobes Industries (Hefei) Co., Ltd. in Hefei. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 19, 2018.

Company Profile

This profile covers Cobes Industries (Hefei) Co., Ltd. based in Hefei, China.

FDA Inspection History

FDA inspections: 3
OAI: 1
VAI: 1
NAI: 0
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected April 28, 2011. Last inspected April 19, 2018.

Most cited issue areas

Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
Design control - no procedures1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
April 19, 2018	Not classified	Medical Devices & Rad Health	1052020
July 17, 2014	VAI	Medical Devices & Rad Health · Compliance: Devices	890159
April 28, 2011	OAI	Medical Devices & Rad Health · Compliance: Devices	730180

FDA documents

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

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