FDA 483 - GlobalMed Holdings, LLC - October 25, 2024

This FDA Form 483 was issued to GlobalMed Holdings, LLC, a medical device manufacturer in Scottsdale, AZ, following an inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, incomplete device master records, and poor documentation of corrective and preventive actions. Further issues involved insufficient control of nonconforming products, unvalidated software, and incorrect device listing information, indicating systemic quality control problems.