483
ZiphyCare, Inc.ZiphyCare, Inc. – FDA 483, Jul 30, 2025
Record Details
An FDA inspection of ZiphyCare, Inc., a medical device manufacturer in New York, revealed significant deficiencies in their quality system. The firm failed to maintain proper Medical Device Reporting procedures, did not submit required device listing information, and lacked proper approval documentation for critical quality system documents.
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ID · 86a0cedf-f468-4500-ac86-9b1ee9d57794
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