# FDA 483 - Estill Medical Technologies, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/estill-medical-technologies-inc/1c4c9b64-9631-4e09-96c2-00a919532396

> FDA 483 for Estill Medical Technologies, Inc on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Estill Medical Technologies, Inc
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Estill Medical Technologies, Inc. in Arlington, TX, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm was cited for inadequate complaint handling, control of nonconforming product, missing documentation, and failures in management review and internal audit processes. Additionally, the company was found non-compliant with Unique Device Identification requirements and had not established an electronic Medical Device Reporting account.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/estill-medical-technologies-inc/64c2342b-5dc3-44ee-bb7c-f6f2367554c7

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