FDA 483 - Precision Dose Inc. - September 11, 2025

Precision Dose Inc., a repackager in South Beloit, IL, was cited for significant deficiencies in its quality control unit, specifically regarding the inconsistent handling of customer complaint investigation extensions, which was a repeat observation. Additionally, the firm failed to properly identify drug products, batch numbers, and processing phases on major equipment and production lines during repackaging activities. These issues indicate a lack of adequate control over critical quality and manufacturing processes.