483
Spineology, Inc.FDA 483 - Spineology, Inc. - February 15, 2022
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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.
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ID · b37c107f-6f95-41da-9ced-886491c80a55