FDA 483 - New Jersey Laboratories - September 22, 2022

New Jersey Laboratories, a control testing laboratory in New Brunswick, NJ, received a Form 483 for deficiencies in their quality unit's investigation procedures. The inspection revealed that investigations into unexplained discrepancies, specifically an Out-of-Specification (OOS) event for residual solvents, were incomplete and lacked proper follow-up, root cause analysis, and corrective actions. This indicates a significant lapse in their quality control processes for handling deviations.