Hospira's Rocky Mount plant meets FDA goals, but one in India does not

Hospira CEO F. Michael Ball

Hospira's ($HSP) long troubled Rocky Mount, NC, manufacturing plant is troubled no more. CEO F. Michael Ball says a much anticipated reinspection of the plant by the FDA resulted in no observations. But now the FDA's focus has shifted to a new plant in India where manufacturing issues have caught its attention.

A warning letter for Hospira's extensive Rocky Mount facility has yet to be cleared by the FDA, executives explained during a call with analysts following the release of its Q2 earnings. But the plant is able to submit new drug applications, and ramped-up production from the facility provided much of the fuel to propel last quarter's financial returns. The company reported sales up 10.7% to $1.135 billion and net income from operations up 90% to $99 million. It now expects adjusted diluted earnings per share for 2014 to range between $2.30 and $2.50 a share.

"Late in the quarter, the FDA inspected our Rocky Mount facility. Five inspectors spent two weeks at the plant, and I am very pleased to report that this much-anticipated inspection resulted in 0 observations," Ball told analysts during a call Wednesday, according to a transcript from Seeking Alpha.

Manufacturing problems for Hospira date back to 2010, and since then the company has invested more than $375 million in upgrading and servicing its facilities. In the first reinspection of the Rocky Mount plant last year, a Form 483 with 20 more observations was received. Hospira has also seen a steady stream of product recalls. In fact, at about the same time that Hospira was discussing its improved situation, the FDA was circulating a MedWatch notice for one lot of Hospira's Lidocaine HCI injection which it is recalling because of particulate found in a vial by a customer.

A new plant the company is building in Vizag, India, is now in FDA sights. The FDA did a preapproval inspection in March and issued a Form 483 with 10 observations, which Hospira has been working on. A few weeks ago, Ball said Hospira received an untitled letter focused on two corrective actions. The company will respond within 30 days and Ball said it is hopeful any reinspection will be done and passed this year and the plant will open as planned. He did not talk about a plant in Irungattukottai, India, that was tagged with a warning letter in May 2013

"Nothing is easy in terms of getting new plants approved or getting plants through inspection," Ball said about the Vizag facilities. "So we feel like that we've got the right personnel behind this and the right equipment, state-of-the-art equipment, I should say, to get this job done."

- here's the earnings release
- read the transcript