FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

First Joint Investigation Leads to EU Ban of Products From Pfizer Site in India

Aug. 23, 2016

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies.

The site, located in Irungattukottai, India, was acquired by Pfizer from Hospira last year as part of a $16 billion acquisition. It produces at least 19 medicines, mostly antibiotics.

According to MHRA’s statement of noncompliance, the inspection identified a critical finding in regard to sterility assurance of product. In addition, the agency found that the environmental monitoring program “was not based on a scientific justification and a number of areas of critical risk were not monitored.” It said sterilization activities featured “poorly designed autoclave load patterns that presented occluded surfaces and areas that were not free draining, SIP process that had pipework that was not appropriately sloped and also had manual interventions that were not appropriately detailed and all of the above issues were linked to a lack of scientific knowledge.”

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