Dixons Surgical Instruments Ltd. – FDA Inspection, Apr 20, 2017

Record Details

This FDA Inspection record concerns Dixons Surgical Instruments Ltd., with an inspection on April 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Dixons Surgical Instruments Ltd.
Inspection Date: April 20, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Stephen C. Smith (FDA Associated Person)

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ID · d5edb95c-19cb-405a-87e2-f87e9c1c7237

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1012423
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.100(b)Documentation
21 CFR 820.90(a)Nonconforming product control
21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements

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FDA Inspection

Dixons Surgical Instruments Ltd.April 20, 2017