August 17, 2017
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FDA to grant ‘voluntary action indicated’ classification to B+L

The FDA will issue a “voluntary action indicated” inspection classification for Valeant’s Bausch + Lomb manufacturing plant in Tampa, Florida, according to a company press release.

This development will eliminate manufacturing uncertainties related to the facility’s regulatory submissions, the release said.

“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,” Valeant chairman and CEO Joseph C. Papa said. “We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility.”