483
Orthocare Innovations, LLCOrthocare Innovations, LLC – FDA 483, Oct 10, 2019
Record Details
An FDA inspection of Orthocare Innovations, LLC in Edmonds, WA, conducted from October 8-10, 2019, identified two significant observations. The firm's purchasing procedures lacked a statistical rationale for raw material sampling during incoming inspection. Additionally, there were no written agreements with suppliers to ensure notification of product or service changes.
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ID · 1f8087aa-5ed1-4f6d-a6ab-844bce861e99
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