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US FDA 483 and 23 observations for Hospira's troubled Indian plant

By Dan Stanton , 06-Jan-2014
Last updated the 06-Jan-2014 at 13:07 GMT

A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticised by the agency again following an inspection last month.

The company revealed last month that the US Food and Drug Administration (FDA) completed an inspection on December 10 of its Irungattukottai plant, near Chennai, India, and issued the site a Form 483 with 23 observations.

“The observations relate primarily to processes and procedures, and the Company does not anticipate any impact to product supply from this plant as a result of the Form 483,” Hospira said in an SEC filing .

The firm added the 483 had been disclosed due to the facility having been subject to an FDA Warning Letter in May last year , following an inspection in October 2012 that uncovered a number of cGMP violations including unsanitary surfaces used during aseptic processing.

At the time, spokesman Dan Rosenberg told Outsourcing-Pharma.com the firm did not believe the Warning Letter “significantly impacts either the scope or timing of [its] remediation efforts” at both the site and its other pharma manufacturing facilities.

With this latest 483, such sentiment was reiterated with the firm saying “the majority of the observations will be addressed over the next several weeks” and it does not anticipate any adverse impact on the company’s financial projections.

483 torrent and Remediation

The 483 came at the end of a year that saw a torrent of warnings and 483s across both Hospira’s drug and device manufacturing network with facilities in Boulder , North Carolina , Kansas , Illinois and Costa Rica subjected to a regulatory ticking off.

Speaking on an investor call to discuss third quarter 2013 results in November , CEO Michael Ball said remediation efforts at one of Hospira’s worst hit facilities - Rocky Mount in North Carolina - would continue into 2014 with management changes, modernization efforts and a new onsite quality and analytical testing laboratory.

Furthermore, a similar remediation programme was to be implemented at the Irungattukottai facility, he told stakeholders, in light of the May Warning Letter and the increased vigilance in overseas inspection.

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