483
New Jersey LaboratoriesNew Jersey Laboratories – FDA 483, Sep 22, 2022
Record Details
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.
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ID · b713587b-7449-4ee8-91d3-e8123584384a
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