Hospira Inc. has received a warning letter from the Food and Drug Administration (FDA) regarding “significant violations” at the drug manufacturing company’s Mulgrave, Australia, plant.
The warning came after the agency inspected the plant and found issues with multiple Hospira injectable drugs including vial-to-vial variability in oxygen levels in the company’s mitoxantrone injections to recurrent instances of visible crystal particles in carboplatin products.
The FDA noted similar violations in May 2012 and April 2013, and that Hospira had not taken effective corrective action to address the problems. The agency also pointed out that the company had received numerous consumer complaints about visible particles in its injections. The warnings do not restrict any of the company’s production or shipment efforts at the Mulgrave plant.
So far in 2014, Hospira has issued six recalls of injectable products ranging from the blood thinner heparin, anesthetics, and heart drugs due to contamination with glass particles, stainless steel, mold and human hair.
Hospira assured the U.S. Securities and Exchange Commission (SEC) that it would fully comply with the agency’s requests and would respond to the warning letter. The FDA did not indicate that it would be satisfied with the response.
“You are responsible for ensuring the quality, safety and integrity of your firm’s products,” the FDA’s warning letter stated. “A fundamental part of this responsibility is preventing the release of defective products and assuring timely resolution of problems that occur.”
Hospira said it was aware that until the violations were corrected the company may be subjected to additional regulatory action by the FDA. “Any such further action could, ultimately, be significant to our ongoing business and operations,” Hospira responded.