The US FDA has completed its re-inspection of Hospira’s Rocky Mount, North Carolina, plant and cited the company with 20 violations, three of which were repeat observations, according to an SEC filing.
The observations deal with issues that were already being dealt with or others previously identified for remediation by Hospira. Those only recently identified will be addressed in the “latter part of the Company's remediation and modernization plans,” Hospira said.
Input from the FDA on the scope and timing of remediation efforts at the facility will be sought by Hospira, though it did not provide any clarity on a timeline or expected costs for its efforts.
The re-inspection, completed March 1, was highlighted in the company’s fourth quarter earnings call in February as being a deciding factor on how much more than the $375m expected for remediation efforts will be necessary.
Hospira’s first quarter 2013 earnings call will include any financial impact from the 483 and remediation efforts, the company said.
“We appreciate the communication the FDA has been providing us, and we look forward to continued dialogue,” Dan Rosenberg, a spokesman of Hospira told Outsourcing-Pharma.com. “While there is still work to be done, we intend to continue balancing our dual commitment of advancing our remediation and modernization plans with delivering needed products to our patients.”
Past Recalls, Warning Letters
The Rocky Mount plant was operating at less than 70% capacity as of February 2012, but executives have not specified its current capacity. In August 2012, Hospira pledged to invest $85m in the plant and create 200 new jobs there, and that investment could reach over $270m in the next decade.
But how much of that investment is related to remediation efforts and whether or not those employees will be let go when the issues are fixed has yet to be described.
Since the earnings conference call last month, Hospira issued recalls of particular lots of five different injectables because of customer reports of contamination and faulty packaging. Problems at its other contract manufacturing plant in North Carolina, as well as at its device plant in Lake Forest, Illinois, will add to the pressure of finishing any remediation efforts in Rocky Mount.