FDA 483 - Bajaj Medical, LLC - August 25, 2025

Bajaj Medical, LLC, a drug manufacturer in Chicago, IL, was cited for deficiencies in its raw material sampling plans. The firm failed to provide scientifically rigorous justification for its sampling methods for critical ingredients like propylene glycol, glycerin, and Specially Denatured Alcohol, particularly concerning global supply chain integrity issues. This could impact the quality and safety of their orally ingested drug products and oral rinses.