Pfizer BSE 0.63 % is the latest
addition to an expanding list of drug makers
found deviating from good manufacturing
practices in India. In the last week of June, a
high profile team drawn from world's four
leading regulators identified a number of
deficiencies at the company's Irungattukottai
facility, near Chennai.
Pfizer has temporarily stopped production at the site. The site, which makes generic injectable drugs, is grappling with adverse reviews for a few years. It was served a warning letter by the US Food and Drug Administration (FDA) in 2013, which was followed up with a handful of observations.
Inspection was led by UK's Medicines and Healthcare products Regulatory Agency (MHRA) and included US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency. The New Yorkheadquartered pharmaceutical giant informed "it temporarily paused production at the site to allow an assessment of observations by appropriate experts". It added, "Our colleagues are fully engaged and working towards resuming production as soon as possible. The temporary pause in manufacturing is being utilized to review the observations, to develop a holistic improvement plan and also to provide additional training to our colleagues at the site".
The injectables unit was formerly owned by Hospira, the injectables maker that Pfizer acquired last year as part of a global $17 billion deal. Hospira had acquired it in 2009 from Orchid Chemicals BSE 0.76 % in a broader $400 million transaction. "A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations," Pfizer said, stating the site is dedicated for exports and does not manufacture for the domestic market. The company ruled out any impact on its employees at the site as a result of the latest inspections. The US FDA and MHRA submitted their inspection observation reports, which Pfizer said it has reviewed in depth. "The site has formally responded to both these agencies and is working diligently to address the specific inspection findings and implement enhancements to site operations," it noted.
Pfizer has temporarily stopped production at the site. The site, which makes generic injectable drugs, is grappling with adverse reviews for a few years. It was served a warning letter by the US Food and Drug Administration (FDA) in 2013, which was followed up with a handful of observations.
Inspection was led by UK's Medicines and Healthcare products Regulatory Agency (MHRA) and included US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency. The New Yorkheadquartered pharmaceutical giant informed "it temporarily paused production at the site to allow an assessment of observations by appropriate experts". It added, "Our colleagues are fully engaged and working towards resuming production as soon as possible. The temporary pause in manufacturing is being utilized to review the observations, to develop a holistic improvement plan and also to provide additional training to our colleagues at the site".
The injectables unit was formerly owned by Hospira, the injectables maker that Pfizer acquired last year as part of a global $17 billion deal. Hospira had acquired it in 2009 from Orchid Chemicals BSE 0.76 % in a broader $400 million transaction. "A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations," Pfizer said, stating the site is dedicated for exports and does not manufacture for the domestic market. The company ruled out any impact on its employees at the site as a result of the latest inspections. The US FDA and MHRA submitted their inspection observation reports, which Pfizer said it has reviewed in depth. "The site has formally responded to both these agencies and is working diligently to address the specific inspection findings and implement enhancements to site operations," it noted.
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