FDA 483 - Dhaliwal Pharmaceuticals Laboratories, LLC - March 01, 2022

Dhaliwal Pharmaceuticals Laboratories, LLC, an OTC drug manufacturer in Mesquite, TX, was cited for failing to follow written production and process control procedures. Specifically, the firm had not completed process validation studies for an OTC topical drug product, leading to the release of unvalidated batches. This indicates a significant lapse in quality control and adherence to manufacturing standards.