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FDA Warning Letter — Olympus Corporation of the Americas

Case 470191 — FEI 2429304

The FDA took a Warning Letter action against Olympus Corporation of the Americas on August 12, 2015 (Center Valley, PA). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Olympus Corporation of the Americas
Date
August 12, 2015
Fiscal Year
2015
Product Type
Devices
Center
CDRH
Location
Center Valley, PA (United States)

Facility

Recent inspections

  • 1107356 (NAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920723 (NAI Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835336 (VAI Fri May 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793907 (OAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709142 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

FDA data resources