Pfizer Pauses To Remedy Quality At Irungattukottai Plant
A more effective approach to quality assurance could result from an operational pause at a Pfizer plant in India, where the company is responding to US FDA inspectional observations of poor data integrity and inadequate investigations that are expected to result in a warning letter.
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US FDA warning letter instructed Pfizer to implement a global corrective and preventive action plan to address widespread data integrity problems. While the impact of the warning letter on the site is expected to be minimal due to its closure, the global impact on the company’s sterile drug operations could be significant.
Pfizer is ending operations at two Indian manufacturing sites, including one with a checkered regulatory history. Approximately 1,700 jobs are at stake as a result of the action, though the US multinational clarified that it is not making a widespread exit from Indian manufacturing.
Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.