Valeant Pharmaceuticals International, Inc. reports that the company’s Bridgewater, New Jersey location received a Warning Letter from the US Food and Drug Administration relating to an inspection in June 2014 of the ccmpany’s records with regards to Sculptra Aesthetic injectable poly-L-Lactic acid, which was divested to Galderma S.A. 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 good manufacturing practice (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 takes all correspondence from the FDA seriously and will be responding to the agency with our improved system and procedure implementations to address the FDA’s concerns shortly,” said Valeant in a statement. “As the issues referenced by the FDA were never at any time regarding the manufacturing quality or safety of any product, we believe that we will be able to resolve this matter in a timely fashion.” 

The Warning Letter may be found here. 

Source: Valeant Pharmaceuticals