FDA Allows Hospira to Make Injectables at New India Plant

Following a series of setbacks that included two failed preapproval inspections and 24 citations, Hospira says the FDA has signaled the all-clear for its new Visakhapatnam, India, manufacturing facility and production is underway.

In a filing with the SEC, the drugmaker says the FDA signed off on its March 18 and May 29 responses to a 14-observation Form 483 that followed a Feb. 16 to 25 preapproval inspection. The company did not provide specifics about the observations.

The news allows Hospira to meet its goal of having the 1.1 million-square-foot sterile injectable drugs facility up and running by the first half of this year. Plans to open the plant by the end of last year were stalled as the firm worked to address concerns in a 10-observation Form 483 stemming from an initial preapproval inspection in March 2014.

Injectables have caused pitfalls at other Hospira plants over the past year. The drugmaker’s Rocky Mount, N.C., and Victoria, Australia, facilities both were cited for good manufacturing practice violations and lax quality controls, including problems with particulates.

The India plant opening will help Pfizer, which is in the process of acquiring Hospira for $17 billion, expand its portfolio of sterile injectables. That deal is slated to close during the second half of the year. — John Bechtel