The warning letter dated January 19, 2017 summarizes significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). The issue of concern is Erwinaze®, an orphan biologic developed by Porton and licensed to Jazz Pharmaceuticals.
"These repeated failures demonstrate that management oversight and control over the manufacture of drugs at your facility is inadequate, and that your previous corrective actions did not address persistent contamination hazards and drug quality issues," FDA writes.
Here are some observed violations and deviations:
Now it is up to Porton Biopharma to respond to the letter within 15 business days and to specify the corrective action taken. A face-to-face regulatory meeting between Porton, Jazz Pharmaceuticals and Agency officials will be scheduled.
Click here to read the lengthy warning letter to Porton Biopharma.
FDA: 2017 Warning Letters