FDA inspection

Rockwell Medical, Inc: FDA inspection ending Sep 11, 2009

FDA inspection 608737 · Voluntary Action Indicated (VAI) · Wixom, MI

Key facts

Inspection ID 608737
Firm Rockwell Medical, Inc
FEI number 3001236991
Address 30142 S Wixom Rd
City Wixom
State MI
ZIP 48393
Country United States
Fiscal year 2009
Inspection end date Sep 11, 2009
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
  • 10–99 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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