April 07--The Food and Drug Administration has warned Hospira that corrective actions the drugmaker made at an Italy facility weren't sufficient, the company disclosed Tuesday in a regulatory filing.
The FDA in a March 31 letter said Hospira lacked written procedures to prevent contamination of its drugs.
Specifically, the FDA said the violations "demonstrate that your quality system does not adequately ensure the accuracy and integrity of the data you generate to support the safety, effectiveness, and quality of the drug products you manufacture."
Hospira said in its filing with the Securities and Exchange Commission that the FDA so far hasn't pressed to "restrict production or shipment" of the company's drugs from the facility.
The FDA inspected the facility in May, and Hospira originally responded to the violations in June. A spokeswoman said the company has "already completed several of the corrective actions ... and the other actions are underway."
Hospira must respond to the letter within 15 business days.
ehirst@tribpub.com
