FDA inspection

Hemagen Diagnostics Inc: FDA inspection ending Jun 14, 2023

FDA inspection 1208393 · Voluntary Action Indicated (VAI) · Baltimore, MD

Key facts

Inspection ID 1208393
Firm Hemagen Diagnostics Inc
FEI number 1181055
Address 2900 Loch Raven Rd
City Baltimore
State MD
ZIP 21218
Country United States
Fiscal year 2023
Inspection end date Jun 14, 2023
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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