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Unipack LLC, a drug manufacturing facility in New Jersey, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection conducted June 11-30, 2025. The firm failed to conduct adequate investigations into out-of-specification (OOS) test results and unknown peaks in chromatograms, including improperly invalidating failed assay results from stability testing without identifying root causes or implementing corrective actions before releasing products for distribution. These violations rendered the company's drug products adulterated under federal law, as their manufacturing methods, facilities, and controls did not conform to CGMP requirements under 21 CFR parts 210 and 211.