|Hospira CEO F. Michael Ball|
Hospira ($HSP) has just picked up an FDA warning letter for a plant in Italy, meaning it now has plants tagged with warning letters on four of the 7 continents: Europe, North America, Asia and Australia. But the problem will be Pfizer's ($PFE) to deal with since it has struck a $15 billion deal to buy the sterile injectable specialist.
The FDA issued a warning letter for the facility in Liscate, Italy, on March 31 and posted it to its website today. It raised questions about the plants vial stoppering procedures, its failure to look deeply enough into complaints and its lack of controls for access to prevent data deletions from test equipment, among other things.
The letter, sent to Hospira CEO F. Michael Ball, told the Lake Forest, IL-based Hospira that it expects it to lay out more specifically how it intends to fix the problems and what actions it intends to take with regard to product it has shipped to customers, whether they will be notified of possible issues and whether products will be recalled.
A Hospira spokesperson said in an email that "Hospira is evaluating what corrective actions may be required to address the specific matters raised in the warning letter. It is important to note that we have already completed several of the corrective actions we committed to the agency in response to the May 2014 inspection observations, and the other actions are underway."
Inspectors were concerned with procedures for putting stoppers in vials that the FDA said could lead to microbial contamination. They noted that concerns were cited during an inspection back in February 2013 and that when they returned more than a year later, the same procedure was still being used. "It did not appear that you had acted on your findings to correct this problem or prevent its recurrence, and the sterility of your products may have been compromised in the meantime," the warning letter says.
Inspectors noted that Hospira had failed to conduct a thorough investigation for 103 customer complaints that related to discoloration of an injectable drug. The FDA chided Hospira for coming to a conclusion about the cause of the discoloration without considering that it "might have been caused by the failure to perform a step in the manufacturing process."
Hospira for years has been battling manufacturing issues that undercut profits and forced it to make big investments in its plants around the world. The warning letter for the plant in Italy is added to those issued for plants in the U.S., India and Australia.
Pfizer was aware of Hospira's manufacturing record when it struck its deal in February to buy the drugmaker. Tony Maddaluna, Pfizer's executive VP of global supply, told investors in a call about the deal that after visiting three sites, Pfizer is comfortable with where its work stands in its efforts to get its facilities up to FDA expectations.
But even since the deal was struck, Hospira has reported that the FDA gave the Vizag, India, plant a Form 483 with 14 observations following a 10-day inspection that was concluded on Feb. 25. Problems meeting FDA expectations has delayed the opening of the 1.1-million-square-foot manufacturing plant in Visakhapatnam that will add about 500 million additional units of sterile injectable drugs to Hospira's supply chain annually. Ball has said that should significantly reduce Hospira's overall cost of products.
- here's the warning letter