483
GURIN PRODUCTS LLCGURIN PRODUCTS LLC – FDA 483, Nov 8, 2019
Record Details
An FDA inspection of GREEN PRODUCTS LLC, an importer of Class II medical devices, revealed significant deficiencies in their quality system. The firm failed to establish and implement procedures for complaint handling, corrective and preventive actions (CAPA), and document control. Additionally, not all complaints regarding their Pulse Oximeters were properly reviewed or evaluated for necessary investigations.
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ID · f832fdaa-b4ba-4c47-badd-2978c47cd394
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