17 August 2017 - - Laval, Quebec-based pharmaceutical and medical device company Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) has received confirmation that the US Food and Drug Administration intends to issue a voluntary action indicated inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida as part of a forthcoming establishment inspection record for the facility, the company said.
With this confirmation, manufacturing uncertainties related to current and upcoming regulatory submissions will be eliminated for products manufactured at the Tampa facility.
"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.
The company has also received approval 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.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.