483
Monitored Therapeutics IncMonitored Therapeutics Inc – FDA 483, Sep 7, 2022
Record Details
An FDA inspection of Monitored Therapeutics Inc. in Dublin, OH, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, internal audits, and employee training. These issues indicate a lack of robust controls over critical quality processes.
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ID · 744583e1-af36-4a1a-b2b9-2cf6a71223eb
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