Valeant Pharmaceuticals' Bridgewater Location Receives Warning Letter from FDA

Valeant Pharmaceuticals International's Bridgewater, New Jersey location received a Warning Letter from FDA relating to an inspection in June 2014 of the company's records with regards to Sculptra Aesthetic injectable, which was divested to Galderma SA in July 2014.

The warning letter pertains to the management of Valeant's contract manufacturers (rather than Valeant's own internal manufacturing) with regard to some specific GMP activities, including review and documentation of supplier's deviation reports prior to batch release and performing corrective and preventive action (CAPA) effectiveness checks as required by procedure. The warning letter does not prevent the manufacturing or distribution of Sculptra nor the manufacture or distribution of any of Valeant's products, and does not relate to the pending review of any Bausch + Lomb compounds.

Valeant says it will be responding to the agency with its improved system and procedure implementations to address the FDA's concerns shortly. As the issues referenced by the FDA were never at any time regarding the manufacturing quality or safety of any product, Valeant believes that it will be able to resolve the matter in a timely fashion.