SteriGear, LLC – FDA 483, Mar 22, 2023
SteriGear, LLC, a medical device specification developer in Pleasant Grove, UT, received a Form FDA 483 with two observations. The inspection revealed deficiencies in complaint handling, specifically regarding the investigation and documentation of issues with their Fig Leaf urinary drainage collection device. Additionally, the firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, with undocumented performance evaluations for their contract manufacturer.
- Office
- Denver District Office
- Person
ID · 104a7738-7fac-4099-8bf2-f23af66d7e1e
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.