FDA 483 - GlobalMed Holdings, LLC - October 25, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- Denver District Office
- Person
ID · 83f8f500-706b-4a94-b8f7-59e7fd7b16a2