Hospira says it received 2 FDA warning letters

NEW YORK

Hospira Inc. said Friday it received a warning letter from the Food and Drug Administration after the agency discovered manufacturing problems at two Hospira facilities in North Carolina.

The Lake Forest, Ill., company said the FDA sent a warning letter dated April 12 after inspecting manufacturing facilities in Rocky Mount and Clayton. Hospira said it was informed that emulsion products at the Clayton facility did not meet manufacturing standards, and the manufacturing processes at Rocky Mount were not properly validated.

Some of the problems were repeat violations that were first discovered in an inspection in April 2009.

The warning letter does not bar Hospira from making or selling any products, but the company said it will delay shipments of some products until it can investigate and discuss the warnings with the FDA. Hospira said it plans to make a comprehensive review of its manufacturing operations to make sure they are in compliance with government standards. It also plans to make a full response to the FDA's letter.

Hospira said it could face additional FDA action until the violations are corrected. those could include refusal to approve new drugs, seizing products, injunctions, or financial penalties.

However the company does not expect the warning or the shipment delays to affect its results this year. In February, Hospira said it expects an annual profit of $3.25 to $3.35 per share in 2010, with revenue of around $3.88 billion.

Shares of Hospira fell 67 cents to close at $57.10, but they earlier set a new year high of $58.13.