Spineology, Inc.February 15, 2022

FDA 483 - Spineology, Inc. - February 15, 2022

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Record Details

An FDA inspection of Spineology, Inc. in Saint Paul, MN, a medical device manufacturer, revealed two significant observations. The firm failed to adequately validate software used in its quality system and demonstrated inadequate risk analysis for incidents involving death or serious injury, specifically regarding documented MDRs.

Company: Spineology, Inc.
Inspection Date: February 15, 2022
Product Type: Device
Office: Minneapolis District Office
People: Albert L. Nguyen
Christina L. Bigham (Investigator )

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ID · b37c107f-6f95-41da-9ced-886491c80a55