Osprey Medical IncMay 24, 2019

FDA 483 - Osprey Medical Inc - May 24, 2019

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Record Details

Osprey Medical Inc. in Hopkins, MN, was inspected from May 22-24, 2019. The inspection revealed that the firm failed to adequately validate its packaging processes for finished DyeVert devices. This finding indicates a significant deficiency in process control and validation procedures.

Company: Osprey Medical Inc
Inspection Date: May 24, 2019
Product Type: Device
Office: Minneapolis District Office
Person: Susan M. Matthias (investigator)

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ID · 75dc8947-f359-4237-939b-8651f2f2b014