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Medical Devices / Inspections and Audits

Oregon Devicemaker Cited for Procedural Issues

Nov. 16, 2018
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The FDA hit US Vascular with a warning letter, calling the firm out for deficiencies that led to the manufacturing of adulterated devices.

The company, which makes class II vascular pathology devices, received a Form 483 following an inspection in March, noting it lacked an adequate design and development procedure.

Specifically, the procedure had no implementation date, and the firm had no proof that it was reviewed or approved.

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