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701961

Rockwell Medical, Inc. — FEI 3003463852

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 8, 2010
Fiscal Year
2011
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))
  • 823241 (NAI Wed Mar 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310821 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
312821 CFR 820.90(a)Nonconforming product control
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.