483
Einstein Works, LLCFDA 483 - Einstein Works, LLC
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Record Details
An FDA inspection of Einstein Works, LLC in Houston, TX, a device manufacturer, revealed a significant deficiency related to Medical Device Reporting. The firm lacks established procedures for MDR and has not set up an FDA Electronic Submissions Gateway account for eMDR. This indicates a serious lapse in regulatory compliance for reporting adverse events.
- Company
- Einstein Works, LLC
- Product Type
- Device
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ID · 1827823e-d590-41ba-a6f0-7e157bdd67e7