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FDA Warning Letter — Arteriocyte Medical Systems Inc

Case 82044 — FEI 3006788678

The FDA took a Warning Letter action against Arteriocyte Medical Systems Inc on December 23, 2009 (Hopkinton, MA). The action was issued by CBER and concerns biologics products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Arteriocyte Medical Systems Inc
Date
December 23, 2009
Fiscal Year
2010
Product Type
Biologics
Center
CBER
Location
Hopkinton, MA (United States)

Facility

Recent inspections

  • 1113436 (NAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057303 (NAI Thu May 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946533 (NAI Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810191 (VAI Tue Dec 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 640530 (NAI Mon Jan 25 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources