Valeant Receives FDA Confirmation Of VAI Inspection For Tampa Facility

(RTTNews) - Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) announced the U.S. Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated or VAI inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Fla. 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.

As further evidence of the progress made at the Tampa facility, the Company received approval yesterday for a Supplemental New Drug Application for the facility to be a release testing facility for drug substance for Alaway (ketotifen fumarate ophthalmic solution), 0.035%.

A VAI inspection classification occurs when objectionable concerns were observed by FDA inspectors at a facility, but the problems do not meet the threshold of regulatory significance.