Valeant Pharmaceuticals International announced that the U.S. Food and Drug Administration (FDA) confirmed it intends to issue a Voluntary Action Indicated (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.
“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 C. Papa, chairman and CEO, Valeant.
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.