FDA confirms issuance of voluntary action indicated inspection classification to Valeant

The US Food and Drug Administration (FDA) has confirmed its intent to issue a voluntary action indicated (VAI) inspection classification for Valeant Pharmaceuticals’ Tampa, Florida manufacturing facility as a part of an upcoming establishment inspection record.

“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.

The VAI inspection classification can be issued in instances where there were objectionable concerns observed by FDA inspectors at a facility but these issues are not considered to be of regulatory significance.

Through confirmation of the VAI inspection classification at Valeant’s Bausch + Lomb manufacturing facility, uncertainties surrounding current and forthcoming regulatory submissions are eliminated.

Furthermore, Valeant has received approval earlier this week for a supplemental new drug application for the facility to become a testing facility for drug substance for Alaway (ketotifen fumarate ophthalmic solution), 0.035%, demonstrating the progress being made.