483
K2 Health Products LLCFDA 483 - K2 Health Products LLC - November 15, 2022
Record Details
K2 Health Products LLC, a medical device initial importer in Brooklyn, NY, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically the lack of written procedures for Medical Device Reporting, complaint handling, and corrective and preventive actions. These observations indicate a fundamental failure to establish essential regulatory processes.
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ID · 8aadafab-bec7-4ed1-84b2-9a28b4d420a4