FDA Issues Warning to Valeant Following Production Problems

Nov 09, 2016

The U.S. Food and Drug Administration issued a warning letter to Valeant following an inspection of its Rochester, New York, facility.

This is just the latest in a string of bad fortunes for the multinational specialty pharmaceutical company, which has seen its stocks fall, its ex-execs under probe and forced to sell critical assets.

The FDA noted various problems with Valeant's “SPAG-2” and “ONSET Mixing Pen” production such as a failure to establish and maintain procedures for validating device design and implementing corrective and preventive actions as required.

Read the FDA's letter