Ms. Laurie Little reports
VALEANT PHARMACEUTICALS' BRIDGEWATER LOCATION RECEIVES WARNING LETTER FROM FDA
Valeant Pharmaceuticals International Inc.'s Bridgewater, N.J., location has 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 regard 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 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 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, the company believes that it will be able to resolve this matter in a timely fashion.
We seek Safe Harbor.
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