Details of the warning letter were revealed in an SEC filing last week, with the US Food and Drug Administration (FDA) citing Hospira’s failures in investigating unexplained batch discrepancies, establishing written procedures for production and process control, and establishing monitoring systems in aseptic processing areas at a facility in Mulgrave, Victoria.
According to Hospira spokesman Ken Griffin, the Warning Letter has no current impact on drug production and “does not restrict production or shipment of medicines from the site.” Furthermore, he told in-Pharmatechnologist.com, the firm has already begun corrective actions relating to the observations.
“Hospira is committed to the highest standards of product and manufacturing quality and we take very seriously our responsibility to ensure we follow regulations and company operating procedures.”
Rocky road towards Rocky Mount?
News of the FDA warning comes two months after concerns were raised by Mulgrave employees in a survey conducted by The National Union of Workers (NUW). The Quality Matters Report said Hospira “has been trying to cut workforce costs and force the introduction of a seven day roster, which would result in fewer workers performing more work.”
This reflects “the same misguided cost cutting mentality that led to significant quality issues during ‘Project Fuel,’ where the company attempted to do more with less after shrinking its global workforce by 10 percent,” the report continued, with workers pleading Hospira not to “turn Australia into a Rocky Mount.”
According to the NUW, Hospira launched Project Fuel in 2009 to “cut costs and deliver highershareholder returns,” though the actual results were a quality crisis and a lawsuit. In April 2010, quality issues at the firm’a North Carolina plant Rocky Mount led to an FDA Warning Letter, which in turn led to supply and shortage issues, and the firm has since invested over $200m (€145m) into remediation efforts.
“Rocky Mount is an important example of why cost cutting does not work in the drug manufacturing business,” the report said. “We do not want Mulgrave Australia to be the new Rocky Mount.”
Earlier this year, 34 members of the 600-strong workforce at Mulgrave lost their jobs “as part of a process to increase the efficiency” of operations, Griffin told this publication last month as the firm announced a $14m into the site.