WHO Prequalification Inspection Services performed an on-site for-cause inspection on Mylan’s Pithampur manufacturing site from 3 to 7 March 2025. This inspection aimed to assess the potential impact of the US FDA findings on the WHO Prequalified products and take any appropriate actions if necessary.
Based on the for-cause on-site inspection at the Mylan Indore site, the PQ inspection team observed that a significant remediation action plan is being implemented to holistically address the issues related to data integrity, testing on packaging materials, backlog of stability samples, and other issues. In addition, the PQ inspection team has found deficiencies related to no timely notification of the out-of-specification (OOS) for the ongoing stability batch of the FPP and inadequate comprehensive investigation of the confirmed OOS.
The PQ inspection services are currently working with the manufacturer to ensure timely action on the affected batch of the FPP. Based on the for-cause on-site inspection, it is determined that there are no direct impact on the quality, safety and efficacy on the FPPs manufactured on-site.
Procurement agencies, distributors and regulatory authorities of Member States are welcome to contact the WHO Inspections Team for further information and updates.
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