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•Terumo Cardiovascular Systems Corp•September 25, 2017

FDA 483 - Terumo Cardiovascular Systems Corp - September 25, 2017

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Record Details

An FDA inspection of Terumo Cardiovascular Systems Corp in Ashland, MA, a manufacturer of Cardiovascular Procedure Kits, identified two significant observations. The firm was cited for inadequate complaint file maintenance, specifically lacking defined processing timeframes and having complaints open for extended periods. Additionally, the inspection found deficiencies in establishing and adhering to equipment preventative maintenance schedules for critical sealing equipment.

Company
Terumo Cardiovascular Systems Corp
Inspection Date
September 25, 2017
Product Type
Device
Office
Division of Northeast Imports 
Person
  • Nabil Nakhoul
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ID · c4479304-b394-414c-a47c-7694f1377d51

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