New Jersey Laboratories – FDA EIR, Sep 22, 2022

An FDA Current Good Manufacturing Practice (CGMP) inspection of New Jersey Laboratories, located in New Brunswick, NJ, was conducted from September 13 to September 22, 2022. The inspection, carried out under Compliance Program 7356.002 (Drug Process Inspections), identified a significant deficiency related to the firm's quality control system. The main violation, documented on an FDA-483 Inspectional Observations form, cited that "Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up." Specifically, an Out-of-Specification (OOS) investigation (OOS # 22-096), initiated on July 29, 2022, remained incomplete for 47 days. It lacked required sign-offs, follow-up on retesting, clear documentation of lab error, a root cause, or corrective actions for a system suitability failure concerning residual solvents testing. Furthermore, the involved instrument continued to be used for other tests, contravening regulatory expectations outlined in 21 CFR 211.192. In response, New Jersey Laboratories' management, led by CEO Ms. Sandra Lee, acknowledged the observation and committed to providing a written response to the FDA within 15 business days, outlining their planned corrections. Notably, during the inspection, the firm initiated a Corrective and Preventive Action (CAPA) and updated its relevant Standard Operating Procedure (SOP QA010), and the specific OOS # 22-096 investigation was reportedly completed and closed.