Hospira ($HSP) has been dealing with FDA concerns for years for plants in the U.S. and more recently in India. But despite being told more than a year ago that it should have a "global corrective action plan" for both its foreign and U.S. plants, new issues have surfaced, this time for a plant in Australia that makes specialty injectable drugs.
The most current letter, for a plant in Mulgrave, Victoria, was concerned about the company's failure to get to the root cause of out-of-specification results for multiples batches of the injectable cancer drug mitoxantrone. There was also a particularly long delay between when it first got word of particles appearing in the chemo drug carboplatin, in May 2012, and when it finally confirmed the issue, in December 2013. Then it was another three months before Hospira gave providers a heads up that they should be watching for particles and should use a filter before administering it.
In an SEC filing last week, Hospira acknowledged the newest warning letter and said it took the issues very seriously. It said it was working to get them resolved. That is a common refrain for the drugmaker, which has spent years of work and tens of millions of dollars in investments to get on top of manufacturing problems with its drug manufacturing plants in the U.S.
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| CEO F. Michael Ball |
Even as it has indicated those problems were mostly resolved, it has had a series of failings for plants in India in the last couple of years. A facility in Irungattukottai was tagged with a warning letter in May 2013 and then received another 23 observations in a follow-up inspection last December. Earlier this year, Hospira CEO F. Michael Ball told analysts that after a preapproval inspection of a plant it is building in Vizag, India, the FDA issued a Form 483 with 10 observations.
On top of those problems, last month, it was reported that an active pharmaceutical ingredient (API) plant in Waluj that Hospira bought from India's Orchid Chemicals & Pharmaceuticals for nearly $220 million, had received a Form 483 three in April. While that inspection came ahead of the closing in July, it means the issues are now Hospira's to resolve.
- here's the SEC filing