- Valeant Pharmaceuticals can add another warning from the Food and Drug Administration to its long list of problems. In a letter posted online this week, the regulator flagged several failures in the Canadian drugmaker's quality control processes at its Rochester, New York facility.
- The plant manufactures medical devices and products tied to Valeant's Bausch + Lomb unit. An FDA inspection in August and September uncovered a number of GMP violations related to production of the OraPharma ONSET mixing pen and a nebulizer system used to administer ribavirin.
- Valeant is also working to resolve manufacturing violations at another facility in Tampa, Florida, which have held up an approval decision for the eye drug Vesneo.
Valeant CEO Joseph Papa made a point to note that the warning letter from the FDA does not impact production and sales of any Bausch + Lomb products.
"We did receive a warning letter for our Rochester, New York site, secondary to inspections in February 2016 and September 2016," said Papa, speaking on an earnings call Tuesday. "We take this issue very seriously and are working with the FDA to resolve it as soon as possible. To be clear, this does not impact production or sales of our Bausch + Lomb products."
According to the FDA's letter, Valeant failed to appropriately validate the designs of both the ONSET mixing pen and the SPAG-2 nebulizer. While Valeant responded to the initial inspection report and detailed plans to revise its design guidance, the FDA found the response to be inadequate as the changes are still in progress.
Valeant also did not set up proper procedures for implementing corrective and preventive field actions around the mixing pen.
While these violations are rooted in process details, the FDA did note the shortcomings are indicative of a broader failing to appropriately integrate acquired products into Valeant's quality management system. Valeant's business strategy, before accounting and pricing scandals necessitated a sharp pivot, had been predicated on growth through heavy M&A.
The FDA's warning letter underscores some of the operational headaches which come with such an M&A-heavy strategy.
Papa indicated Valeant expected the issue at the Rochester plant to be resolved quickly, while also noting the Tampa facility would likely be ready for a re-inspection by the end of the year.