Valeant resolving Tampa facility issues with the US FDA

Canada’s Valeant Pharmaceuticals International (TSX: VRX) says the US Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida, as part of a forthcoming Establishment Inspection Record for the facility.

With this confirmation, manufacturing uncertainties related to current and upcoming regulatory submissions will be eliminated for products manufactured at the Tampa facility. Valeant shares rose 1.8% to $14.15 yesterday, and a further 1.2% to $14.32 in after-hours trading.

"Following continued close collaboration with FDA inspectors, today, the FDA confirmed that all issues related to a Current Good Manufacturing Practice inspection at the Tampa facility are being satisfactorily resolved, and VAI status will soon be granted to the facility. We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility," said Joseph Papa, chairman and chief executive of Valeant.