FDA slaps warning letter on Crescita plant sold by Valeant

A former Valeant dermatology manufacturing plant in Laval, Quebec, that makes Premiology brand products has been issued an FDA warning letter.

A manufacturing facility that Integra Skin Sciences picked up last year as part of its deal to buy Valeant’s Groupe Cosméderme dermatology brands has run into problems with the FDA. The agency, which inspected the dermatology products plant in Laval, Quebec, several months after the deal was announced, has issued it a warning letter. Montreal-based Integra has since been sold to another Canadian firm focused on dermatology products. 

The FDA letter was posted last week after being issued Dec. 15. It follows a visit in May in which inspectors discovered the dermatology product plant was not adequately investigating any unexplained discrepancies of any batches or any of their components. It said the facility didn’t even have written procedures that would ensure a quality unit would investigate batches.

Inspectors also cited the facility for not validating its equipment cleaning procedures, for not having written procedures for handling customer complaints or procedures for production and process control that would make sure its products met the strength, quality and purity which they claimed to meet.

The agency said that if the facility was going to continue to manufacture products for the U.S. market then its owner should consider bringing in a consultant that can help it get its manufacturing operations up to FDA standards.

Its ownership has actually changed a second time since Valeant sold it. Montreal-based Integra Skin Sciences a year ago announced it was buying Groupe Cosméderme from Valeant for an undisclosed sum. The deal included the Laboratoire Dr Renaud, Pro-Derm and Premiology brands, as well as the Laval manufacturing plant. As part of the deal, Integra also agreed to manufacture select products for Valeant for a minimum of three years. Then in September, Integra was picked up by Crescita Therapeutics, a Mississauga, Ontario-based skin care company, for $8 million plus $2 million in milestones.