Valeant Moves Forward with Mfg Facility Operations
Valeant Pharmaceuticals International, a specialty pharmaceutical company, reports that the US Food and Drug Administration (FDA) intends to issue a Voluntary Action Indicated (VAI) inspection classification for the company’s Bausch + Lomb manufacturing facility in Tampa, Florida as part of a forthcoming Establishment Inspection Record for the facility. The company says with confirmation of this classification, manufacturing uncertainties related to current and upcoming regulatory submissions will be eliminated for products manufactured at the Tampa facility.
A VAI inspection classification occurs when objectionable concerns were observed by the FDA inspectors at a facility, but the problems do not meet the threshold of regulatory significance.
“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 CEO, Valeant, in a company statement.
The company recently received approval for a supplemental new drug application for the facility to be a release-testing facility for the drug substance for Alaway (ketotifen fumarate ophthalmic solution, 0.035%), an eye-care product.
Source: Valeant Pharmaceuticals