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483
•KX Medical Inc•January 21, 2025

KX Medical Inc – FDA 483, Jan 21, 2025

Record Details

An FDA inspection of KX Medical Inc in Gallatin, TN, from January 15-21, 2025, identified one observation. The firm's procedures for acceptance activities were found to be inadequate. Specifically, the procedures failed to designate an individual for final product release and did not mandate the signature of an authorized individual.

Company
KX Medical Inc
Inspection date
January 21, 2025
Product type
device
Office
New Orleans District Office
Person
  • Nikki S. Bryant (investigator)
View Company Profile

ID · cda64966-848a-437b-99dd-92b13e45bf9f

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