Valeant Issued FDA Warning Letter
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
The Warning Letter may be found here.
Source: Valeant Pharmaceuticals