FDA 483 - Dalton Chemical Laboratories Inc. - December 09, 2022

Dalton Chemical Laboratories Inc. in North York, a drug manufacturer, was inspected from 12/1/2022 to 12/9/2022. The inspection revealed significant deficiencies in aseptic processing, process controls, out-of-specification investigations, stability testing, laboratory controls, and cleaning validation. These issues indicate a failure to prevent microbiological contamination and assure drug product quality and purity.