483
Alliance Tech Medical, IncFDA 483 - Alliance Tech Medical, Inc
Record Details
Alliance Tech Medical, Inc. in Granbury, TX, a device manufacturer, received a Form FDA 483 with three observations. The inspection revealed deficiencies in the firm's complaint handling processes, including inadequate documentation for uninvestigated complaints and a failure to investigate complaints involving potential device failures. Additionally, the firm did not submit a required written report to the FDA concerning a corrective action for a product quality issue.
- Company
- Alliance Tech Medical, Inc
- Product Type
- Device
Open in Dashboard
ID · 3e45a04a-f4c1-4563-9a03-d07c66dfa86b