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•Spectramed LLC•October 26, 2022

FDA 483 - Spectramed LLC - October 26, 2022

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Record Details

An FDA inspection of Spectramed LLC, a medical device specification developer in Columbus, OH, identified two observations. The firm failed to adequately document the evaluation of potential suppliers and did not ensure that employees used current revisions of approved documents. These issues indicate deficiencies in the firm's quality system regarding purchasing and document controls.

Company
Spectramed LLC
Inspection Date
October 26, 2022
Product Type
Device
Office
Cincinnati District Office
Person
  • Rosanna M. Goodrich (Medical Device Specialist)
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ID · 405183ec-11ba-421e-9ac4-538de3fe62f0

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