# FDA 483 - Quality Aspirators, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/quality-aspirators-inc/d3852e18-0fc6-4451-b48f-aaf10a8b646d

> FDA 483 for Quality Aspirators, Inc on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quality Aspirators, Inc
- Product Type: device
- Office Name: Dallas District Office
- Summary: Quality Aspirators, Inc., a device manufacturer in Duncanville, TX, was cited for three observations during an FDA inspection. The firm had inadequate procedures for handling complaints and device history records, and failed to establish an FDA Electronic Submissions Gateway account for eMDR. These issues indicate deficiencies in their quality system and regulatory compliance.

## Related Documents

- [483 - 2025-04-23](https://www.globalkeysolutions.net/records/483/quality-aspirators-inc/94dd5734-b180-4493-aa61-1fd04b75f371)

## Related Officers

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

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

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