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Valeant’s Tampa Facility Receives FDA VAI Classification

Following collaboration with FDA, issues related to a cGMP inspection are being resolved

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By: Kristin Brooks

Managing Editor, Contract Pharma

Valeant Pharmaceuticals received confirmation from the FDA that it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, FL 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, 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 chief executive officer, Valeant.

Following progress made at the Tampa facility, the company recently received approval for a Supplemental New Drug Application for the release testing 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.

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