483
Equashield LLCFDA 483 - Equashield LLC - December 08, 2021
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Record Details
Equashield LLC, a medical device importer in Port Washington, NY, was inspected by the FDA, revealing a significant compliance issue. The firm failed to maintain written Medical Device Reporting (MDR) procedures. Specifically, it lacked electronic MDR procedures and an Electronic Submissions Gateway (ESG) account for handling serious injury and death incidents.
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ID · d6bc99bc-a8d5-45e7-b347-b887bfff3e83