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

Source: https://www.keypedia.com/records/483/epitope-diagnostics-inc/3580cf50-e508-4b21-af3d-a6c7abbc5a0f

> FDA 483 for Epitope Diagnostics, Inc. on April 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Epitope Diagnostics, Inc.
- Inspection Date: 2023-04-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/epitope-diagnostics-inc/d5642a4a-6034-4f05-a7e7-3a2b3ea5116c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6