FDA 483 - June Jacobs Labs, LLC - November 04, 2024

An FDA inspection of June Jacobs Labs, LLC in Moonachie, NJ, revealed significant deficiencies in their manufacturing processes for drug products. The firm failed to conduct investigations for out-of-specification product, lacked proper control over labeling and packaging materials, and released drug products without adequate final testing. These observations highlight critical lapses in quality control and good manufacturing practices.