|Hospira CEO F. Michael Ball|
When Pfizer announced its $15 billion deal to buy sterile injectable specialist Hospira, execs said they had studied FDA concerns over Hospira manufacturing before pulling the trigger. But Hospira ($HSP) just keeps giving Pfizer ($PFE) new lessons. Today, the FDA posted a warning letter it recently sent to Hospira CEO F. Michael Ball for a plant in Italy.
The letter for the facility in Liscate, Italy, chastises the drugmaker for not thoroughly investigating 103 customer complaints received over a two-year period about the discoloration of a product. The FDA said when Hospira did investigate, its conclusions were shortsighted. It never occurred to the drugmaker that the cause might have been tied to faulty manufacturing.
The FDA warning also cites problems with an aseptic filling line that raised questions about potential microbial contamination, as well as indications that employees had been deleting or overwriting test results on computerized testing equipment, a big no-no with the FDA.
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."
It is not as if Hospira is unfamiliar with FDA expectations. It has been dealing for years with problems the FDA found at plants in the U.S. But despite having to invest hundreds of millions of dollars in upgrades and untold lost sales from plant interruptions, problems have continued to materialize at its plants around the world. In fact, it now has plants tagged with warning letters on four of the 7 continents: Europe, North America, Asia and Australia.
A new plant in India, the opening of which has been delayed by FDA concerns, received a new list of FDA issues a few weeks after the Pfizer deal was announced. The massive plant in Visakhapatnam is supposed to significantly reduce Hospira's operating costs, so is key to the company. It was one of three plants that Pfizer's Executive VP of Global Supply Tony Maddaluna told investors he had visited before the deal was announced and which convinced him Hospira was on the right track.
A Pfizer spokesperson declined to comment since the deal has yet to close.
- here's the warning letter