483
The Pyure Company IncThe Pyure Company Inc – FDA 483, Jan 20, 2023
Record Details
The FDA inspected The Pyure Company Inc in Boynton Beach, FL, a manufacturer of the MDU/Rx Air Purifier. The inspection revealed significant deficiencies in design control, including undocumented design input requirements and inadequate design transfer procedures. Additionally, the firm failed to properly evaluate and select critical component suppliers, indicating a moderate level of non-compliance with quality system regulations.
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ID · 3acd765a-037d-40b2-aa64-01f5dc85b5c9
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