Hospira Slammed with Another Warning Letter by the FDA - Analyst Blog

Hospira Inc. HSP received disappointing news when the FDA slammed a warning letter related to the company’s manufacturing facility in Liscate, Italy. The letter however does not restrict the production or shipment of Hospira's pharmaceutical products from the facility.

Hospira, which is currently evaluating the issues raised in the warning letter, plans to respond fully and in a timely manner. Also the company said that until the matter is resolved, the FDA may take additional regulatory actions which may affect the company’s ongoing business and operations.

Hospira is no stranger to FDA warning letters. The company had received several warning letters in the past related to its different manufacturing facilities across the globe. In Sep 2014, the FDA had issued a warning letter to the company following an inspection of the company’s pharmaceutical manufacturing facility located in Mulgrave, Victoria, Australia.

Our Take

The FDA warning letter is concerning. This is beginning to be a recurrent overhang for the company given its history of past warning letters. Further regulatory actions may affect Hospira’s revenues significantly.

We note that Hospira is set to be acquired by Pfizer Inc. PFE. The deal, valued at approximately $17 billion, is expected to close in the second half of 2015. We expect investor focus to remain on the transaction.

Hospira carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care space include Acorda Therapeutics, Inc. ACOR and Affymetrix Inc. AFFX, both holding a Zacks Rank #1 (Strong Buy).


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