The US Food and Drug Administration (FDA) has served a Form 483 - a list of objectionable conditions identified during its inspection -to Hospira Inc’s pharmaceutical manufacturing facility at Irungattukottai, Sriperumbudur, near here. The FDI is the regulator for all drugs sold in the US. The company said the observations were primarily related to processes and procedures and it would address the issue in the next several weeks. In a filing with the United States Securities and Exchange Commission, Hospira said the FDA had completed an inspection of the Irungattukottai facility on December 10.
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