483
Blephex, LLCFDA 483 - Blephex, LLC - March 28, 2019
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.
Record Details
An FDA inspection of Blephex, LLC in Franklin, TN, identified two significant observations. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints. Additionally, Blephex, LLC lacked written Medical Device Reporting (MDR) procedures, indicating a need for improved quality system documentation and implementation.
- Person
Open in Dashboard
ID · 9550a68d-91a0-4c00-a153-9eaddda8f0fa