Hospira Inc., which was acquired by Pfizer in February for $17 billion, has received another U.S. FDA warning letter detailing violations at its plant in Liscate, Italy
Last May, FDA inspectors visited Hospira's Liscate plant twice, identifying significant violations, including failure to establish contamination prevention procedures and failure to thoroughly investigate failed batches. According to the FDA, Hospira's response to the inspection concerns lacked "sufficient corrective actions."
The March 31st letter does not restrict the production or shipment of pharmaceutical products from the facility, however, the FDA did threaten to withhold approval of new applications if the facility is not compliant.
Read the Reuters press release