The 1.1m sq foot Visakhapatnam facility (known as the Vizag plant) in the Andhra Pradesh region of India has been delayed in commencing production by a number of Form 483s from the US Food and Drug Administration (FDA).
But in an SEC filing last week Hospira announced its response to the latest 483 – which contained 14 observations relating to an inspection in February this year – had resulted in the Agency deeming the plant “acceptable for the manufacture of finished dosage drugs.”
“As a result of this action, the Company may receive U.S. product approvals from this facility in the future,” the filing continued. “Hospira responded to the Form 483 on March 18, 2015, and submitted additional support documentation on May 29, 2015. The inspection was found to be acceptable following the FDA’s review of the Company’s responses and support documentation.
“The Company has begun limited commercial production at the facility.”
The firm – which is set to be acquired by Pfizer for $17bn – had also received a 483 with ten observations in the first quarter 2014.
Speaking at the time, CEO Michael Ball said he had expected the plant to come on line by the end of 2014 but then the plant received the second 483 in January.
Hospira’s second sterile manufacturing plant, the Irungattukottai (IKKT) in facility in Chennai, has also had regulatory issues having being subjected to an FDA Warning Letter in 2013, citing a number of cGMP violations.