Drug recall lawyers at Pintas & Mullins Law Firm report that Hospira Inc. is again under fire from the FDA over, among many things, unsanitary conditions at its pharmaceutical manufacturing plant in India. This most recent federal warning is just the latest in a slew of negative letters and inspection reports.
Between June 2012 and June 2013, Hospira has received four warning letters from the FDA, two of which concerning the practices at the Indian plant. The company has also received about six “483 Inspection Reports,” which the FDA issues when production plants are not following federal regulations. Dating back to 2011, there were seven additional 483 Inspection Reports.
Understandably, this leads many officials to raise concerns about drug contamination in Hospira’s products, which include sterile injections and infusion pumps. These pumps, in fact, were recently subject to an importation ban by the FDA.
We reported in November 2012 that Hospira officials were accused of failing to maintain manufacturing equipment. Since then, the company has been cited for other major violations, such as failing to properly clean surfaces and using damaged gloves when handling sterile products. The FDA stated that it was particularly concerned about the violations it witnessed at Hospira’s Rocking Mount, North Carolina facility.
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The federal agency noted that it may withhold approval of new products from Hospira and even prohibit any of the company’s products made in India from entering the U.S. This is because, year after year, Hospira continues to affirm that progress is being made. For example, in late May 2013, the company stated that the bulk of its problems will be resolved by the end of the year, although, ambiguously, some will “obviously linger.”
Hospira recently hired a new head of operations, a new head of regulatory, a new head of quality, and a new chief medical officer. Additionally, all five Hospira plants in the United States now have new plant managers. Although this management overhaul provides promise for the future, it also indicates how deep-rooted the systemic problems actually were, and will probably continue to be.
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For example, Hospira hired a new senior VP of operations in 2012, a seasoned vet who spent 25 years overseeing operations at GlaxoSmithKline. Just last month, in April 2013, he was replaced. The company continues to manufacture and sell its products, despite this regulatory drama, because it makes medications that are desperately needed and in short supply.
Among these include four injectable cancer treatments (carboplatin, cytarabine, paclitaxel, methotrexate) which were recalled in July 2012. The recall was initiated because many of the drugs’ glass vials had visible particles
into them. Other critical drugs include intravenous treatment to nourish premature infants.
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In the last three years, since the FDA commissioner vowed to crack down on plant inspections, the agency has warned six major injectable drug manufacturers that were violating regulations, resulting in considerable slow-downs in production. This led to the current shortage of critical drugs, making compounding pharmacies an attractive alternative. This over-reliance on compounding pharmacies has had, of course, disastrous and deadly results.
Other manufacturing companies found to have quality issues include Teva, Ben Venue (a faction of Boehringer Ingelheim), Luitpold Pharmaceuticals, and Sandoz. At A.P.P. Phar
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