# FDA 483 - Quality Bioresources, Inc - December 19, 2024

Source: https://www.globalkeysolutions.net/records/483/quality-bioresources-inc/aac8b716-b456-4538-8906-b203aad3c9d3

> FDA 483 for Quality Bioresources, Inc on December 19, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Quality Bioresources, Inc
- Inspection Date: 2024-12-19
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Quality Bioresources, Inc. in Seguin, TX, a medical device and manufacturer, identified four significant observations. The firm exhibited deficiencies in batch production and control records, including inadequate documentation for manufacturing steps, product disposition, and yield determination. Additionally, the inspection revealed a lack of established written procedures and validation for production processes, insufficient employee training, and poor control over labeling operations, particularly concerning expiration date extensions.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/quality-bioresources-inc/3fa63e69-7126-4059-9bfb-cea6b26ecb7f

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