Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures for devices fall short of expectations.
The letter, included in a recent SEC filing, presents the devicemaker and injectable drugmaker with a devastating setback just as Rocky Mount was beginning to emerge from remediation — activity that has included third-party reviews to address particulates and other quality issues.
CEO Michael Ball says remediation at Rocky Mount and the company’s other manufacturing facilities have cost the company half a billion dollars over the last three years, and in an investor call last month, he said a successful FDA inspection later this year could get the plant back to normal.
But the warning letter, dated March 7, could impact the plant’s progress just as it began preparing new products for approval. In the letter, which follows a Sept. 30, 2013, to Nov. 15, 2013, inspection, investigators observed that CAPA procedures relating medical device manufacturing “have not been adequately established.” The agency notes Hospira has several CAPAs aimed at preventing future non-compliances but has not established measures to prevent potential problems while the plans are being implemented.
“In addition, several corrective and preventive action activities and/or results have not been adequately documented,” the letter reads. “During our inspection, several CAPAs were observed to be closed without any effectiveness checks.”
The letter also notes that Hospira doesn’t always document staff training activity.
The March 7 FDA letter was related to an inspection of device-related matters at the plant and does not impact the compliance status of pharmaceutical operations at the site, spokesperson Tareta Adams said. Rocky Mount only makes one product that is registered as a device — a sterile empty PCA container, Adams noted.
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