483
June Jacobs Labs, LLCFDA 483 - June Jacobs Labs, LLC - November 04, 2024
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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.
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ID · dfc673db-fd14-478c-b100-c25f0db90416