FDA 483 - Dhaliwal Laboratories LLC - June 26, 2025

Dhaliwal Labs South LLC, a manufacturer in Dallas, TX, was inspected and cited for significant deficiencies in its quality control and production processes. Observations included a failure to fully qualify stability chambers for OTC drug products, a lack of proper change control for new equipment, and inadequate equipment cleaning and use logs for its filling line. These issues indicate a lack of adherence to established procedures and controls.