# FDA 483 - Einstein Works, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/einstein-works-llc/1827823e-d590-41ba-a6f0-7e157bdd67e7

> FDA 483 for Einstein Works, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Einstein Works, LLC
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.globalkeysolutions.net/companies/einstein-works-llc/74be6dba-a998-4559-88bf-ed57c40d128e

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9