483
Spectramed LLCSpectramed LLC – FDA 483, Oct 26, 2022
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.
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ID · 405183ec-11ba-421e-9ac4-538de3fe62f0
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