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

An FDA inspection of Epitope Diagnostics, Inc., a medical device manufacturer in San Diego, CA, took place from April 24 to April 28, 2023. The inspection resulted in a Form FDA 483 listing two significant observations related to the company's quality system, indicating potential non-compliance with federal regulations.

The first observation cited the lack of established written procedures for Medical Device Reports (MDRs). The firm's Quality Assurance specialist confirmed the absence of such essential documentation, which is crucial for reporting adverse events associated with medical devices.

The second observation detailed inadequate procedures for receiving, reviewing, and evaluating customer complaints. Although complaint-related communications were retained, the company failed to consistently file complaint reports on the required "QSR Form 12B," as mandated by their internal "Customer Complaints Procedure." This represents a lapse in adhering to their own documented quality protocols for complaint management.

Epitope Diagnostics, Inc. has committed to addressing these observations by implementing corrective actions for both issues within 12 weeks of the inspection date. These corrective measures are necessary to ensure the firm's compliance with the quality system requirements outlined in the Federal Food, Drug and Cosmetic Act, particularly concerning post-market surveillance and complaint handling for medical devices.