Hospira Struggles Further under FDA Scrutiny

One FDA scrutiny after another continues to plague pharmaceutical and medical device manufacturer Hospira. These inquiries continue even after pharma giant Pfizer agreed to buy Hospira in a US$17 billion deal in February 2015. However, the scrutiny of Hospira’s manufacturing facilities by the FDA continues.

The company was summoned yet another time by the regulator relating to alleged discrepancies found in one of its facilities based in Italy. In May 2014, the FDA had zeroed-in on ‘significant’ violations by Hospira in its manufacturing practices pertaining to finished pharmaceuticals. The result of these faulty manufacturing practices, according to the FDA, results in ‘adulterated’ drugs being produced. The company then offered a response to these findings but the FDA remained firm on its stance that the company did not have ‘sufficient’ corrective actions. 

The reported problems with Hospira’s manufacturing facilities and processes have been going on for some time now. In fact, less than a week after the Pfizer-Hospira deal was announced, the latter had to recall over 60 batches of its pain relieving injections in the Singapore and U.S. market. The recall was on account of floating particles that were observed in the glass vials.

In December 2014, the company had to recall multiple batches of one of its many cancer drugs because the FDA found that the drug was not potent enough and that it had elevated levels of impurities. 

Besides, in recent months, the FDA found inconsistencies in the company’s facilities in Australia, India and the United States, which led the regulatory body to issue warning letters to the company.


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