Hospira Inc. has received a warning letter from the U.S. Food and Drug Administration related to an inspection of the drugmaker’s operations at an Australian plant.
The FDA letter, which Hospira said it received Monday, said the company had not adequately fixed production problems found during an inspection of the Mulgrave, Australia, plant between Feb. 24 and March 1. The plant makes specialty injectable drugs.
“The company is evaluating what corrective actions may be required, and associated costs may be incurred, to address the matters raised in the warning letter,” Hospira said in a statement. “The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA’s warning letter.”
Lake Forest-based Hospira said it doesn’t expect the warning letter will affect its 2014 financial guidance.
