483
WIDE USA CORPORATIONWIDE USA CORPORATION – FDA 483, Nov 27, 2019
Record Details
An FDA inspection of WON USA CORPORATION in Anaheim, CA, an initial importer, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for evaluating complaints to determine if Medical Device Reporting was required. Additionally, the company lacked established written procedures for document control, including approval, distribution, and changes.
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ID · 0427dfda-ad06-498c-ba9b-a2dd7bee041b
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