The US regulator gave the plant a clean bill of health in a closeout letter this month, explaining that: “Based on our evaluation, it appears that you have addressed the violations and or deviations.”
The Sermoneta facility – which was previously owned by Bristol Myers - makes oral and sterile liquid dosage forms antibiotics, including cephalosporin and penicillins. It was also cleared to manufacture freeze-dried cancer drugs for clinical trials in July 2015.
CordenPharma – which is owned by Germany-based International Chemical Investors Group (ICIG) – said addressing the issues – which were detailed in a warning letter in May last year – had involved a “holistic and systematic approach.”
The firm declined to comment further when contacted by in-Pharmatechnologist.com.