Jazz Pharmaceuticals' CDMO -- UK-based Porton Biopharma -- received a Warning Letter from the FDA regarding cGMP violations noted during an on-site inspection.
Porton is the sole manufacturer of Jazz's Erwinaze, an orphan drug approved in the U.S. to treat acute lymphoblastic leukemia in patients with allergies to E. coli derived chemotherapy drugs.
The Warning Letter notes Porton's failure to remedy cGMP violations cited in a January 2015 on-site inspection despite assurances to do so. Similar deficiencies were noted again in a recent inspection in March 2016.
The FDA has requested a face-to-face regulatory meeting between Porton, Jazz, and Agency officials.
Read the FDA Warning Letter