In an effort to bring its quality up to speed, the company hired a trio of pharmaceutical veterans, including Dr. Leslie Benet, former chair of the FDA Expert Panel on Individual Bioequivalence, Dr. Allen Chao, former CEO of Watson Pharmaceuticals, and Peter Terreri, president and CEO of the manufacturing company CGM.
The executives may help alleviate concerns that the Hayward, Calif.-based manufacturing site was not going to return to quality manufacturing after violations cited by the FDA over the last two years.
History of Issues
Most recently, the site was cited in a FDA Form 483 from March for 12 observations. Violations included “inadequate” validation methods performed for the NDA (New Drug Application) for Rytary (levodopa/carbidopa), a potential treatment of idiopathic Parkinson’s disease, rejected by the agency in January. That rejection caused GlaxoSmithKline to end its development deal with Impax.
In addition, the Form 483 found that established manufacturing process parameters at the plant were not validated, cleaning procedures and operations were cited as deficient and employees at the plant “lack the training and experience required to perform their assigned functions.”
Bryan Reasons, SVP & CFO of Impax said last week at the Bank of America Merrill Lynch Health Care Conference that the company submitted responses to the Form 483 on March 21. The company also requested a meeting with FDA’s San Francisco District Office “to ensure plans and actions are in alignment with the FDA’s expectations,” he said.
The company also continues to transfer products from Hayward to its other production plant in Taiwan, Reasons said.
The release of the Form 483 followed the FDA’s announcement in April that Impax’s 300 mg dose of Budeprion XL was not therapeutically equivalent to the reference listed drug Wellbutrin XL 300 mg, which forced Impax to recall the drug. That announcement followed an FDA-sponsored bioequivalence study from 2010.
Prior to bioequivalence issue, the same California plant received a warning letter from the FDA in 2011 that included a repeat observation from an April 2010 inspection.
Impax did not respond to a request for comment on the new committee of specialists.