483
Sodium Systems LLCFDA 483 - Sodium Systems LLC - October 22, 2025
Record Details
Sodium Systems LLC, a medical device manufacturer in Ann Arbor, MI, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in supplier qualification, design validation, device history records, complaint handling, and unique device identification marking for reusable devices. These issues indicate a need for comprehensive improvements in their quality system.
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ID · d40bf237-5737-4ffc-b658-c2e74d2cc8c1