FDA Inspection 1317040 - Hemagen Diagnostics Inc - May 14, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Record Details

This FDA Inspection record concerns Hemagen Diagnostics Inc, with an inspection on May 14, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Hemagen Diagnostics Inc
Inspection Date: May 14, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

Open in Dashboard

ID · 20bb5642-0ae1-46d9-9cde-e8506784a2a8

Violation Codes3

ISO 13485:2016 Clause 4.2.5ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 8.5.2

Full citation text and observation details available on the Dashboard.