Pharmaceuticals / Regulatory Affairs / GMPs / Inspections and Audits

FDA Upgrades Troubled Hospira Plant as Remediation Continues


The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products.

Hospira executives heralded the change during a Feb. 12 conference call with investors as an acknowledgement from the agency of the company’s remediation progress. The drugmaker isn’t out of the woods yet, as the plant remains under a warning letter issued in 2010 for lax quality control and particulate issues.

Rocky Mount needs to have a successful FDA inspection for the warning letter to be closed, and that inspection could come later this year, CEO Michael Ball said on the call.

The quality problems forced a temporary slowdown at Rocky Mount, and Hospira has said that company-wide remediation has cost close to half a billion dollars since 2010.

Production at Rocky Mount has been steadily ramping up, and officials said the status upgrade from the more severe “official action indicated” to “voluntary action indicated” could help Hospira’s drug pipeline.

“There are potential products in the future that we can place in those particular facilities,” said Sumant Ramachandra, senior VP and chief scientific officer, during the investor call.

The drugmaker expects to seek FDA approval this year or in early 2015 for a biosimilar of Amgen’s oncology drug Epogen (epoetin alfa). Hospira is also conducting Phase I clinical trials on biosimilars of Amgen’s Neulasta (pegfilgrastim) and Neupogen (filgrastim).

While Hospira appears to be on track to resolve Rocky Mount’s quality issues, other facilities have been flagged by the FDA.

In August, the injectable giant’s McPherson, Kan., facility received a Form 483 for an inadequate response to finding glass particles in sterile lyophilized drugs. During the plant inspection, the agency found that investigations into the particles were conducted long after discovery. Hospira’s Irungattukottai, India, facility was also warned last year for extensive good manufacturing practice violations such as failing to sanitize surfaces prior to use.

Hospira has worked to “resolve the vast majority of issues that they had brought up [with the India plant],” Ball said.

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