FDA inspection

Rockwell Medical, Inc.: FDA inspection ending Sep 16, 2024

FDA inspection 1251365 · Voluntary Action Indicated (VAI) · Grapevine, TX

Key facts

Inspection ID 1251365
Firm Rockwell Medical, Inc.
FEI number 3003463852
Address 4051 Freeport Pkwy Ste 100
City Grapevine
State TX
ZIP 76051
Country United States
Fiscal year 2024
Inspection end date Sep 16, 2024
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
Product type Devices

At a glance

  • 1–9 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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