Motion Concepts LPNovember 16, 2023

FDA 483 - Motion Concepts LP - November 16, 2023

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Record Details

Motion Concepts LP, a medical device manufacturer in Concord, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in the firm's quality system, specifically concerning inadequate documentation of corrective and preventive actions, insufficient establishment of supplier requirements, and non-objective risk analysis procedures. These issues indicate potential weaknesses in ensuring product safety and quality.

Company: Motion Concepts LP
Inspection Date: November 16, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Benjamin J. Dastoli (Investigator )

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ID · 585d3958-f627-4998-96bf-57895e7ceac8