FDA 483 - Dhaliwal Labs North, LLC - May 09, 2025

Dhaliwal Labs North, LLC, an OTC drug manufacturer in Bedford Park, IL, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualification of their water system, a lack of essential microbiology method suitability studies and Burkholderia cepacia complex testing, and a failure to follow change control procedures for equipment. These issues indicate a lack of robust production, laboratory, and quality control processes.