483
Advanced Medical InnovationsAdvanced Medical Innovations – FDA 483, Aug 20, 2021
Record Details
An FDA inspection of Advanced Medical Innovations, a Class I and II medical device manufacturer in Northridge, CA, revealed a significant quality system deficiency. The firm failed to adequately validate processes for sterile Ultimate Sharp Safety Stations, specifically by not conducting required dose audits and bioburden testing for several years. This indicates a serious lapse in ensuring product sterility and safety.
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ID · 10c5c004-5f93-4257-a873-e17247eeadf4
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