FDA Warning Letters Hit Three Repackers For Failing To Identify Original API Makers

The US Food and Drug Administration recently issued three drug GMP warning letters to drug repackers of active pharmaceutical ingredients for omitting the name of the original manufacturers of the active pharmaceutical ingredients to customers, a common practice in the API sector that the agency wants to stop.

The three repackers were all in the US: B&B Pharmaceuticals in Englewood, CO; Asclemed USA, also known as Enovachem, in Torrance, CA; and Spectrum Laboratory Products in Gardenia, CA.