FDA Issues Warning Letters to Three API Repackers For GMP Violations

05 Jul 2019

• By Akriti Seth

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards.

Quality_Control — Various API repackers have come under scrutiny over quality control issues • Source: Shutterstock

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...