The federal safety watchdog, in a Nov. 3 warning letter posted online today, wrote that inspections from Aug. 23 through Sept. 1 turned up problems with its small-particle aerosol generator, the SPAG-2 device, and a high-precision compound and dispensing pen, the OraPharma OnSet mixing pen.
The FDA flagged Laval, Canada-based Valeant for 5 violations of good manufacturing practices, corrective & preventive action, and maintaining adequate organizational structure, according to the letter:
- Failure to establish and maintain procedures for validating the device design;
- Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verifications, review and approval of design changes before their implementation;
- Failure to establish and maintain procedures for implementing corrective and preventive action;
- Failure to establish and maintain procedures for to control product that does not conform to specified requirements;
- Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
The violations come 1 week after news broke that Valeant is reportedly exploring a sale of its eye surgery business that could be worth as much as $2.5 billion. Valeant is in discussions with 3rd parties for “various divestitures”, according to the Wall Street Journal, although the company won’t give up the contact lenses, solutions and eye drugs that it acquired with its $9 billion purchase of Bausch & Lomb in 2013.