483
Slater Endoscopy, LLCSlater Endoscopy, LLC – FDA 483, Feb 2, 2023
Record Details
Slater Endoscopy, LLC, a medical device manufacturer in Miramar, FL, was inspected by the FDA from January 31 to February 2, 2023. The inspection revealed a deficiency in document control procedures, specifically regarding the updating of Design History Files and Device Master Records after material and process changes. This indicates a moderate compliance issue related to quality system documentation.
View Company Profile
ID · 5a508b1e-f87c-4f42-ae17-0ae627f77172
Other documents for Slater Endoscopy, LLC
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.