Carclo Technical Plastics Shanghai Co., Ltd., Shanghai, China – FDA Inspections

Inspection records and compliance data for Carclo Technical Plastics Shanghai Co., Ltd. in Shanghai. 2 FDA inspections on record, last inspected August 07, 2014.

Company Profile

This profile covers Carclo Technical Plastics Shanghai Co., Ltd. based in Shanghai, China.

FDA Inspection History

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

First inspected April 22, 2010. Last inspected August 7, 2014.

Most cited issue areas

Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
Lack of or inadequate DHR procedures1 inspection
Legibility1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
August 7, 2014	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	896794
April 22, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	659705

FDA documents

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

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