483
Neodontics IncNeodontics Inc – FDA 483, Jan 24, 2023
Record Details
An FDA inspection of Neodontics Inc, a Class II medical device manufacturer of dental alloys in Sun Valley, CA, revealed two significant observations. The firm failed to maintain device history records for its dental alloys and did not establish unique device identifiers (UDI) for its products, which were also missing from the device history records.
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ID · 26cfd4a7-6279-4fc7-8d52-a9c304e6352b
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