483
Electromed, Inc.Electromed, Inc. – FDA 483, Feb 12, 2026
Record Details
An FDA inspection of Electromed, Inc. in New Prague, MN, a medical device manufacturer, revealed two significant observations. The firm's procedures for controlling nonconforming product were found to be inadequately documented, specifically lacking processes for investigation and recording results. Additionally, the receiving inspection process for critical components was not adequately implemented, failing to follow established sampling plans.
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ID · f6eb8a26-4a65-45f9-a57b-55f65495fb9b
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