Valeant Pharmaceuticals' Bridgewater Location Receives Warning Letter From FDA
LAVAL, Quebec, Sept. 30, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. today announced that the company's Bridgewater, New Jersey location received a Warning Letter from the U.S. Food and Drug Administration (FDA) relating to an inspection in June 2014 of the Company's records with regards to Sculptra Aesthetic injectable, 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. 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.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (nyse/tsx:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
This press release may contain forward-looking statements, including, but not limited to, statements regarding improved system and procedure implementation and the ability resolve this matter in a timely fashion. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Contact Information: Valeant Pharmaceuticals:Investors:
Laurie W. Little
Valeant Pharmaceuticals International, Inc.
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SOURCE Valeant Pharmaceuticals International, Inc.