Epitope Diagnostics, Inc.April 28, 2023

FDA 483 - Epitope Diagnostics, Inc. - April 28, 2023

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Epitope Diagnostics, Inc.

Record Details

An FDA inspection of Epitope Diagnostics, Inc. in San Diego, CA, revealed two significant issues related to quality system procedures. The firm failed to develop written procedures for Medical Device Reports and inadequately established procedures for receiving, reviewing, and evaluating complaints. These observations indicate deficiencies in the firm's quality management system for medical device manufacturing.

Company: Epitope Diagnostics, Inc.
Inspection Date: April 28, 2023
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Juanj Wu

Open in Dashboard

ID · 3580cf50-e508-4b21-af3d-a6c7abbc5a0f