FDA 483 - Textile-Based Delivery Inc. - June 05, 2025

Textile-Based Delivery Inc. in Conover, NC, was inspected by the FDA from June 2-5, 2025, and received a Form 483 citing a significant deficiency in its quality system. The firm failed to maintain adequate records for evaluating drug product quality standards, specifically by not performing Annual Product Reviews or having written procedures for reviewing batches for potential issues. This indicates a lack of robust quality oversight for its manufacturing processes.