Hospira says approval for its new manufacturing facility in India is still on track despite receiving a Form 483 form the US FDA with ten observations.
Hospira has previously predicted its new 1.1m sq ft speciality injectable pharmaceutical Vizag plant in the Andhra Pradesh region of India would go online by the end of 2014, but during a conference call discussing Q1 2014 results, the firm announced a recent inspection had left the facility with a US Food and Drug Administration (FDA) Form 483.
“The FDA came in and gave us 10 observations associated with the inspection,” CEO Michael Ball told investors. “Five of them, we had already previously self-identified ourselves.”
According to Ball, the issues revolve around training and supplier quality at the site, and are problems the firm feels it is equipped to deal with.
“We will be providing responses back into the agency and having a discussion with them as we move forward,” Ball continued, “but overall, we still are expecting, or at least our assumption is that we'll get approval for this plant sometime this year.”
For the first quarter, sales were up year-over-year by 19% to $1.05bn (€757m), whilst the bottom line was up a similar percentage to $101m.
Capital spending for the quarter was $95m, up from $69m the same period last year. “The increase reflects additional planned spending related to plant modernization efforts and the development of our new Vizag facility,” CFO Thomas Werner said on the call.
Untitled Letter at second Indian plant
in-Pharmatechnologist.com contacted Hospira for further details regarding the 483, as well as an untitled letter from the FDA at a second Indian plant - the IKKT sterile production facility in Irungattukottai – but no further information was disclosed.
However, Ball said on the call IKKT – which was subject to a Warning Letter in May 2013 and subsequently inspected in December - received the letter in April.
“The untitled letter was based on the December inspection and our corresponding response,” he said. “We will be responding to the untitled letter in due course, but do not expect it to have significant impact to the financial or operational performance of the plant.”
Rocky Mount update
Over the past few years, Hospira has been hit with a number of 483s and FDA warnings across its manufacturing network. Much of the focus has been on the Rocky Mount, North Carolina, US facility which was subject to a 2010 Warning Letter citing a number of cGMP and quality violations.
Much work has been done there (including $200m of remediation), allowing the firm to report an FDA upgrade to the site last quarter, and management is optimistic the FDA will be back for a follow up inspection later this year.