Starboard Medical (Jiangsu) Co., Ltd. – FDA Inspection, Jul 23, 2019

Record Details

This FDA Inspection record concerns Starboard Medical (Jiangsu) Co., Ltd., with an inspection on July 23, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Starboard Medical (Jiangsu) Co., Ltd.
Inspection Date: July 23, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Rosanna M. Goodrich (FDA Associated Person)

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ID · 527e45ba-3c6c-45ca-bd34-643f1d03de8f

Inspection Facts

Inspection number: 1098235
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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FDA Inspection

Starboard Medical (Jiangsu) Co., Ltd.July 23, 2019