CordenPharma said it had been warned by the Food and Drug Administration (FDA) last week. The firm explained that the US regulator is concerned about deviations from current good manufacturing practices (cGMP) observed during a visit to the Sermoneta facility in May 2015.
The firm said it plans to respond to the letter within 15 days and stressed that the supply of active pharmaceutical ingredients (APIs) and finished dosage forms made at the facility will not be impacted.
Spokesman Michael Quirmbach told us: “Corden Pharma Latina is doing everything to close the gaps and working closely with FDA.
“A cease of production as well as import to US is not the focus of the warning letter and Corden Latina will continue to serve US Market without any restriction” adding that the warning letter will soon be published by the FDA.
The facility in Sermoneta central Italy – which was previously owned by US drug maker Bristol Myers - makes oral and sterile liquid dosage forms antibiotics, including cephalosporin and penicillins.
According to CordenPharma the facility was also cleared to make freeze-dried cancer drugs for clinical trials in July last year.
CordenPharma is owned by Germany-based International Chemical Investors Group (ICIG).
The US FDA has now published the warning letter.