October 2, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
The Lake Forest, IL-based pharmaceutical and medication drug delivery company Hospira, Inc. has announced that it received a warning letter on Monday from the U.S. Food and Drug Administration (FDA) regarding its Australian manufacturing facility in Mulgrave, Victoria, chiding the firm for not sufficiently correcting manufacturing problems observed by the FDA during an inspection of the plant between February 24 and March 1 of this year.
The letter, posted in an 8-K filing by Hospira, states that, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.” In addition, the FDA could refuse admission into the US products manufactured at the Mulgrave plant if Hospira. The company has 15 days to respond to the letter by informing the FDA of the steps it has taken to rectify the manufacturing problems.
In the 8-K filing, Hospira states, “The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA’s warning letter.”
Though the FDA warning letter does not restrict the production of or the shipment of products from the Mulgrave plant at this time, Hospira acknowledges in the filing that, “There can be no assurance that the FDA will be satisfied with the company’s response. Until the violations are corrected, the company may be subject to additional regulatory action by the FDA. Any such further action could, ultimately, be significant to our ongoing business and operations.”
The company indicates in the same document that it does not believe the warning will impact its 2014 financial guidance.
The Mulgrave plant makes specialty injectable drugs. The “significant violations” observed by the FDA during the February inspection included “visible particles” in an injectable drug, reported Chelsey Dulaney of the Wall Street Journal. The FDA letter reads, “During our inspection of your pharmaceutical manufacturing facility, Hospira Australia Pty, Limited located…[in] Mulgrave, Victoria, Australia, dated February 24 through March 1, 2014, investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals….These violations cause your drug product(s) to be adulterated.”
The FDA acknowledged that Hospira did respond to the infractions noted, however, the response was insufficient. In the most recent warning letter, the FDA states, “We have conducted a detailed review of your firm’s response dated March 21, 2014 and note that it lacks sufficient corrective actions.”
Hospira, which claims to be the leading provider of injectable drugs and infusion technologies, employs 15,000 people worldwide. The company, which was formerly the hospital products division of Abbott Laboratories, was spun off from Abbott in 2004.
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