Interesting article - especially where they were cited for not properly construct the facilities for manufacturing, processing and handling the product. If they can't get the building build properly - the first important task, what about the next important task - manufacturing safe, effective, quality standard products?
http://www.chicagobusiness.com/article/20131220/NEWS03/131229976/more-fda-woes-for-hospira#
Article -
The Food and Drug Administration has identified nearly two dozen problems at a Hospira Inc. drug manufacturing plant in India that the Lake Forest company says are related to “processes and procedures.”
The agency on Dec. 10 inspected the facility in Irungattukottai, a small town in southern India, according to a filing the injectable drug maker submitted to the Securities and Exchange Commission today.
The filing did not go into specifics of the issues cited in the FDA's report, called a Form 483, though the company notes that they were related to “processes and procedures.”
“The Company does not anticipate any impact to product supply from this plant as a result of the Form 483,” the filing states.
The disclosure comes as CEO F. Michael Ball continues to try to push a long run of FDA issue behind the company, which recorded Hospira's net sales rose just 1.4 percent, to $1.01 billion during the third quarter, up from $994.0 million, during the third quarter, 2012.
The same facility was the subject of a warning letter from the agency in May. That letter, also filed with the SEC, noted that the company failed to follow procedures intended to prevent microbial contamination of its drug products and didn't have appropriately constructed facilities for manufacturing, processing and handling of products.
“The Company takes this matter seriously, and intends to respond fully, and in a timely manner, to this Form 483,” the SEC filing states.
The company swung to a profit of $29.8 million, from a loss of $16.5 million during the third quarter, 2012. The stock price has climbed by nearly a third this year, closing at $41.27 a share on Friday, up from $31.24 a share on Dec. 31, 2012.
Hospira doesn't anticipate that the FDA form will have an impact on its ability to meet its financial guidance for 2013.
Irungattukottai is near of Chennai, a city with more than 4 million people on the coast of the Bay of Bengal
http://www.chicagobusiness.com/article/20131220/NEWS03/131229976/more-fda-woes-for-hospira#
Article -
The Food and Drug Administration has identified nearly two dozen problems at a Hospira Inc. drug manufacturing plant in India that the Lake Forest company says are related to “processes and procedures.”
The agency on Dec. 10 inspected the facility in Irungattukottai, a small town in southern India, according to a filing the injectable drug maker submitted to the Securities and Exchange Commission today.
The filing did not go into specifics of the issues cited in the FDA's report, called a Form 483, though the company notes that they were related to “processes and procedures.”
“The Company does not anticipate any impact to product supply from this plant as a result of the Form 483,” the filing states.
The disclosure comes as CEO F. Michael Ball continues to try to push a long run of FDA issue behind the company, which recorded Hospira's net sales rose just 1.4 percent, to $1.01 billion during the third quarter, up from $994.0 million, during the third quarter, 2012.
The same facility was the subject of a warning letter from the agency in May. That letter, also filed with the SEC, noted that the company failed to follow procedures intended to prevent microbial contamination of its drug products and didn't have appropriately constructed facilities for manufacturing, processing and handling of products.
“The Company takes this matter seriously, and intends to respond fully, and in a timely manner, to this Form 483,” the SEC filing states.
The company swung to a profit of $29.8 million, from a loss of $16.5 million during the third quarter, 2012. The stock price has climbed by nearly a third this year, closing at $41.27 a share on Friday, up from $31.24 a share on Dec. 31, 2012.
Hospira doesn't anticipate that the FDA form will have an impact on its ability to meet its financial guidance for 2013.
Irungattukottai is near of Chennai, a city with more than 4 million people on the coast of the Bay of Bengal