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Valeant's NJ location receives warning letter from FDA

Valeant announced that its Bridgewater, NJ, location received a warning letter from the U.S. Food and Drug Administration regarding a June 2014 inspection of records pertaining to its Sculptra Aesthetic injectable, according to a company press release.

Sculptra (injectable poly-L-lactic acid) was divested to Galderma S.A. in July 2014.

The warning letter addresses the management of Valeant’s contract manufacturers, as opposed to Valeant’s own internal manufacturing, regarding some specific Good Manufacturing Practice activities. These include the review and documentation of supplier’s deviation reports prior to batch release, as well as the performing of the required corrective and preventive action effectiveness checks.

The warning letter does not prevent the manufacturing or distribution of Sculptra or any other of Valeant’s products, nor does it relate to the pending review of any Bausch+ Lomb compounds, according to the press release.

Valeant stated it will respond to the agency shortly with an improved system and procedure implementation to address the FDA’s concerns.

“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 company stated in the press release.