Thursday, October 2, 2014

Hospira Guilty of Having Foreign Particles in Injectable Medications According to The FDA


FDA cites Hospira for drug manufacturing violations

Drugmaker Hospira said Wednesday that it received a warning letter from the (FDA) Food and Drug Administration regarding poor manufacturing quality at one of its facilities in Australia.

The FDA inspected Hospira's drug manufacturing building in Mulgrave, a suburb of Melbourne. Hospira manufactures specialty injectable drugs including mitoxantrone at the facility.

The FDA wrote that there were “significant violations of current good manufacturing practice regulations for finished pharmaceuticals,” according to a company disclosure. For example, the agency said that it found impurities in the injectable drugs and that it appeared Hospira was unaware of the situation.

Lake Forest, Ill.-based Hospira said the warning letter would not halt production or shipment of drugs from the facility, and it “is evaluating what corrective actions may be required.”

“The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA's warning letter,” Hospira said in its filing. Hospira officials were not available for further comment.

Hospira does not anticipate the issue will dampen its 2014 financials, but if the FDA demands large-scale changes, it could “be significant to our ongoing business and operations,” Hospira said.

Warning letters from the FDA are not entirely uncommon among pharmaceutical companies. To date in 2014, the FDA has issued a dozen warning letters to drugmakers based on manufacturing or product quality concerns.

Hospira's specialty injectable drugs were a big driver in the company's improved earnings in the second quarter of this year.

No comments:

Post a Comment