# FDA 483 - MedHab, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/medhab-llc/220bc568-83ad-4609-a103-4b7c904c3b22

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

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## Details

- Record Type: 483
- Company Name: MedHab, LLC
- Product Type: device
- Office Name: Dallas District Office
- Summary: Medhab, LLC, a device manufacturer in Arlington, TX, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern inadequate management reviews, insufficient internal audits, and failures in corrective and preventive action implementation. Additionally, the firm lacked documented personnel training, used unapproved documents, and had no established procedures for device recalls.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/medhab-llc/5caa23e0-79b3-477e-8233-cec14cef6bb6

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