The inspection uncovered a number of cGMP violations that the company failed to adequately provide corrective actions for. The violations included unsanitized surfaces during the filling of an injection and other sterility issues, particularly with gloves used during aseptic processing.
“We are in the process of reviewing the warning letter [from May 28], but do not believe that it significantly impacts either the scope or timing of our remediation efforts at [Irungattukottai, India] or our other pharmaceutical manufacturing plants,” Hospira spokesman Dan Rosenberg told Outsourcing-Pharma.com. He also noted that this warning letter is not expected to have an impact on the company’s 2013 financial guidance.
This is the latest in a series of violations cited by the FDA and some analysts wonder if the agency will issue a consent decree against the company.
“When we consider the bigger picture, we maintain that enforcement action remains likely. The FDA cannot simply be giving out warning letters that are based on old information and not reflective of reality and the current status,” said Shibani Malhotra, an analyst at RBC Capital Markets, according to Forbes.
Despite the concern of a consent decree, Hospira says it is making progress in solving the issues at a few of its plants in the US and abroad.
“We’ve made a lot of progress with our pharmaceutical remediation efforts,” Rosenberg said. “We are in regular dialogue with the pharmaceutical side of the FDA. The company has made significant improvements to our plants – in the form of people, processes and modernization, although we still have work to do with our remediation efforts.”
In addition, a number of drugs on the FDA’s shortage list are manufactured by Hospira, which leads some to believe the FDA is looking to work with the company closely to resume production.