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

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.