The June visit to the Irungattukottai sterile manufacturing site involved inspectors from four regulatory bodies - the UK’s MHRA, the US FDA, Health Canada, and Australia’s TGA – a Pfizer spokeswoman told this publication.
“At the time of the inspection Pfizer temporarily paused production at the site to allow an assessment of observations by appropriate experts.”
The manufacturing hold remains, it was confirmed, and “a holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.
“The site is fully engaged and is working towards resuming production as soon as possible.”
Before becoming part of Pfizer’s manufacturing network in the $17bn merger last year, Hospira had been struggling to overcome a 2013 US Food and Drug Administration (FDA) warning letter which cited a number of sterility issues observed at the plant.
A reinspection in December 2013 resulted in Hospira being issued a Form 483 with 23 observations related to the processes and procedures.
This latest inspection resulted in another FDA 483, the spokesperson said, but was unable to divulge how many observations were cited.
However, we were told “Pfizer has formally responded to the inspection findings issued following the recent inspection.”
In a filing submitted to the Bombay Stock Exchange this morning, Pfizer India refused to comment on the news. saying any problems at the plant do "not relate to Pfizer Limited, India" and instead relate to "an unlisted Indian subsidiary of Pfizer Inc., USA."
Hospira’s network has suffered from a long line of regulatory issues. Between 2012 and the end of 2014, the firm implemented 40 product recalls due to quality problems, and the recalls have kept coming since.
At the time the merger was announced, Pfizer said it felt “comfortable that issues raised by regulators either have been, or are being properly and adequately addressed” after visiting three of the firm’s most problematic facilities: Rocky Mount, North Carolina, which was hit with a warning in 2010, a device facility in Costa Rica, and a sterile injectables facility in Vizag, India which received a 483 with ten observations in 2014, before operations had even commenced.