FDA Raises Safety Concerns at Hospira, Inc. Plant in India

Published: May 30, 2013

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Hospira Inc said it received a warning letter from the U.S. Food and Drug Administration raising concerns about contamination of drugs manufactured at its facility in India. The letter followed an October inspection of the facility in the southern Indian state of Tamil Nadu, where the FDA said it had found significant violations of quality regulations for finished drugs. The FDA said it found that surfaces in the facility were not always sanitized prior to use and that sterile drug products were not protected from contamination. Hospira entered into an agreement in August to buy a factory and research center from India-based Orchid Chemicals & Pharmaceuticals Ltd in a bid to reduce costs.

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