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483
•Healthplus LLC•August 7, 2025

FDA 483 - Healthplus LLC - August 07, 2025

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Record Details

An FDA inspection of Healthplus LLC in Asheville, NC, from August 4-7, 2025, identified one significant observation. The firm failed to adequately validate the design of a Class II medical device using initial production units, lacking sufficient records to confirm the manufacturing and acceptance of devices used in validation activities. This indicates a deficiency in their design control processes.

Company
Healthplus LLC
Inspection Date
August 7, 2025
Product Type
Device
Office
Atlanta District Office
Person
  • Gamal A. Norton
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ID · 31d7bbec-94c0-4ecb-a9e6-c6a1d1ca7aa5

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