Orthosoft, Inc. – FDA Inspection, Feb 14, 2019

Record Details

This FDA Inspection record concerns Orthosoft, Inc., with an inspection on February 14, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Orthosoft, Inc.
Inspection Date: February 14, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Brian S. Keefer (FDA Associated Person)

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ID · a8ab1a07-2b51-401b-a473-97b8792bf5ad

Inspection Facts

Inspection number: 1079773
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(g)Design validation - simulated testing

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FDA Inspection

Orthosoft, Inc.February 14, 2019