483
Blephex, LLCFDA 483 - Blephex, LLC - March 28, 2019
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.
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ID · 9550a68d-91a0-4c00-a153-9eaddda8f0fa