# FDA 483 - Bioteque America, Inc - April 23, 2025

Source: https://www.globalkeysolutions.net/records/483/bioteque-america-inc/964f95c0-b584-44a6-a565-cd66be0ecb55

> FDA 483 for Bioteque America, Inc on April 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioteque America, Inc
- Inspection Date: 2025-04-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: Bioteque America, Inc. in Richardson, TX, a manufacturer of Class I/II gynecological medical devices, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate procedures for MDRs, supplier management, corrective and preventive actions, risk analysis, equipment maintenance, and a complete lack of UDI listings in the GUDID for its products. These issues indicate a broad failure to maintain a compliant quality system.

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/bioteque-america-inc/e370fa61-6e31-4ac8-848f-ac0e02ad621e

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