January 27, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – The U.S. Food and Drug Administration issued a warning letter to U.K.-based Porton Biopharma for continued regulatory violations in the manufacturing process, particularly a leukemia drug made for Jazz Pharmaceuticals .
The FDA visited Porton’s manufacturing facilities in March 2016 when it discovered the violations, including “significant deviations from CGMP (current good manufacturing practice) for active pharmaceutical ingredients (API).”
FDA inspectors found particulate matter in 237 batches of Jazz Pharma’s Erwinaze, an injectable treatment for leukemia. The FDA said Porton did not “adequately investigate” the issue. The FDA said Porton’s quality control officers identified the stopper used in the vials as the source of the metal particulates, but instead of addressing the stoppers, Porton updated its standard operating procedure “by adding foreign material as a subcategory” in its rejection criteria. The FDA also criticized the company for not finding an alternative stopper supplier, even though the company had identified several possible sources.
“Your firm’s corrective action and preventive action (CAPA) plan was inadequate. You did not investigate how you manage incoming stoppers or your supplier’s stopper manufacturing process until after the inspection…,” the FDA said in the letter.
But, it wasn’t just Porton that the FDA criticized for failing to address the manufacturing problems. The FDA said as a partner, Jazz Pharmaceuticals also has a responsibility to assure the “quality of drugs released and ultimately administered to patients.”
This was the second warning letter the FDA sent to Porton. In 2015 the regulatory agency inspected Porton’s facilities and cited the company for violations of current good manufacturing practice. In the Jan. 19 letter, the FDA said “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.”
Porton is required to submit a response to the FDA in early February.
“Until you correct all violations and deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the FDA said.
If the contract manufacturing company does not address the problems to the satisfaction of the FDA, the regulatory agency said it could block drugs manufactured by Porton from entering into the United States.
