483
ZiphyCare, Inc.ZiphyCare, Inc. – FDA 483, Sep 6, 2022
Record Details
An FDA inspection of ZiphyCare, Inc. in New York, NY, a specification developer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for supplier evaluation, design changes, document control, and software validation. These issues indicate a broad lack of control over their medical device development and manufacturing processes.
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ID · 91fd6e33-1b69-4c36-b39c-84924aaee163
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