Hemagen Diagnostics Inc, Baltimore, MD – FDA Inspections

Inspection records and compliance data for Hemagen Diagnostics Inc in Baltimore, Maryland. 6 FDA inspections on record, 2 Form 483s, last inspected May 14, 2026.

Company Profile

This profile covers Hemagen Diagnostics Inc based in Baltimore, Maryland, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 3
NAI: 3
Form 483s: 2
Warning letters: 0

First inspected August 25, 2010. Last inspected May 14, 2026.

Most cited issue areas

Corrective action not taken1 inspection
Corrective action procedures not documented1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
May 14, 2026	VAI	Medical Devices & Rad Health · Compliance: Devices	1317040
June 14, 2023	VAI	Medical Devices & Rad Health · Compliance: Devices	1208393
January 10, 2018	VAI	Medical Devices & Rad Health · Compliance: Devices	1037233
March 10, 2015	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	918077
December 20, 2012	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	812190
August 25, 2010	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	677299

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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