Another Nasty 483 for Hospira

Another Nasty 483 for Hospira

November 13th, 2013 // 6:00 pm @

Hospira this week got another 483, this time for three cGMP violations for its plant in Kansas. Most of the focus on Hospira has been with the Rock Mount NC plant and all of the problems and warning letters it has gotten from FDA. But CEO Michael Ball also told stakeholders last week about a 483 at the Kansas plant.

Specifically, the McPherson, KS plant got a 483, and that plant focuses on injectable generics. It was expanded back in 2006 at a cost of $60 million.

Also, the Hospira plant in Boulder, CO was inspected in the second quarter and two 483 observations were noted there.

The medical device industry for Hospira also has seen several quality problems lately, specifically in Lake Forest IL. There has been a threat of the suspension of ISO certification after an audit by the National Standards Authority of Ireland. There also has been an import ban on products from that plant.

For the import ban to be lifted, FDA would have to reinspect the Costa Rica Hospira plant, as well as the one in Lake Forest.

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