Hikma says FDA has closed out warning letter for EU injectables plant

Just over a year ago, a Hikma sterile injectables plant in Portugal was grilled in a FDA warning letter for a variety of failings, some that the agency said it had been warned about before. But Jordan-based Hikma said today that the FDA has indicated those problems are behind it.

While the FDA has yet to publicly file it, the drugmaker announced it had received a closeout letter saying the FDA had evaluated and signed off on Hikma's corrective actions at the facility in Fervenca. This will allow the company to again seek approvals for new meds for the U.S. market, something that essentially had been precluded from that plant as long as the company had the warning letter hanging over it.

Hikma CEO Said Darwazah

"I am very pleased that we have brought our Portuguese facility back into compliance with the U.S. FDA," Hikma CEO Said Darwazah said in a statement. "We believe that the resolution of the Warning Letter will enable us to accelerate the introduction of new products to the market, ensuring we continue to broaden the range of critical medicines we supply to patients in the US."

The drugmaker had quite a lot to resolve. The October 2014 warning letter cited the company for not getting to the root of nearly two dozen instances in which environmental monitoring samples exceeded action levels, deciding instead they must be false positive readings. That meant it hadn't bothered to check further to see if products had been compromised as a result, the FDA had said.

The company also was written up for the its incubation of media plates ahead of use, which the FDA said might impede media growth and affect monitoring, something the plant had been cited for in inspections three times before.

Several years ago Hikma considered selling off its injectables business, but now has been investing heavily in it, which has served it well. Last year it acquired Boehringer Ingelheim's Ben Venue injectable business.

- read the release