The US Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients, including opioids, for significant violations of current good manufacturing practice requirements. The companies under question are B&B Pharmaceuticals, Asclemed USA – trading as Enovachem – and Spectrum Laboratory Products.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research said “the supply chain issues we have found in the API repacking industry broadly pose a real threat to...