UPDATE 1-Hospira gets warning letter from U.S. FDA

Fri Apr 16, 2010 5:09pm EDT

* FDA cites two North Carolina facilities

* Hospira holding back some shipments

LOS ANGELES, April 16 (Reuters) - Hospira Inc (HSP.N), a maker of hospital products, medical devices and injectable drugs, said on Friday it had received a warning letter from the U.S. Food and Drug Administration after an inspection of two manufacturing plants in North Carolina.

The FDA cited deficiencies related to particulate in emulsion products at its Clayton plant and a failure to adequately validate manufacturing processes at its Rocky Mount facility, Hospira said in a regulatory filing.

The warning letter does not restrict production or shipments from the plants, but the company said it was withholding shipments of certain products pending its further investigation and discussions with the FDA.

Other cited inadequacies include procedures related to quality control, investigations and medical device reporting obligations, Hospira said in the filing.

The FDA letter asserts that some deficiencies were repeat observations from a prior inspection conducted in April 2009, and include a similar violation cited in an Aug. 12, 2009 warning letter to Hospira's Morgan Hill, California facility.

Hospira said it would undertake a comprehensive review of its manufacturing operations to ensure compliance with regulations. The company also said it did not expect the matters to adversely affect its ability to achieve 2010 financial projections. (Reporting by Deena Beasley; Editing by Ted Kerr)

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