# FDA 483 - Quality Aspirators, Inc - April 23, 2025

Source: https://www.keypedia.com/records/483/quality-aspirators-inc/94dd5734-b180-4493-aa61-1fd04b75f371

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

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## Details

- Record Type: 483
- Company Name: Quality Aspirators, Inc
- Inspection Date: 2025-04-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: Quality Aspirators, Inc. in Duncanville, TX, a contract manufacturer of Class 1 and Class 2 medical devices, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in environmental controls, including undocumented pest control and structural issues, as well as inadequate equipment maintenance schedules for manufacturing equipment. These issues indicate a lack of established procedures to ensure product quality and safety.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/quality-aspirators-inc/d3852e18-0fc6-4451-b48f-aaf10a8b646d)

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/quality-aspirators-inc/91b37b9d-bd18-40b2-8cee-d75a5f7ca954

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