FDA Issues Warning to Valeant Following Production Problems

Warning letter highlights Valeant's inability to integrate products that were gathered through acquisition
Nov. 9, 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

Sign up for Pharma Manufacturing Newsletters
Get the latest news and updates