Valeant's Bridgewater Location Gets FDA Warning Letter

(RTTNews) - Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) said Tuesday that its Bridgewater, New Jersey location received a Warning Letter from the U.S. Food and Drug Administration relating to an inspection in June of the company's records with regards to Sculptra Aesthetic injectable, which was divested to Galderma S.A. in July.

The Warning Letter pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing, with regard to some specific Good Manufacturing Practice activities, including review and documentation of supplier's deviation reports prior to batch release and performing corrective and preventive action 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 said.

Valeant said that 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.