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823241

Rockwell Medical, Inc. — FEI 3003463852

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 20, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Grapevine, TX (United States)

Facility

Other inspections at this facility

  • 1251365 (VAI Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175266 (VAI Mon Jul 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959876 (NAI Wed Jan 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701961 (NAI Wed Dec 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
311321 CFR 820.70(g)Equipment design and installation
311721 CFR 820.70(i)Software validation for automated processes
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
54621 CFR 820.75(a)Lack of or inadequate process validation