WHO Public Inspection Reports (WHOPIRs) In Vitro Diagnostics

Each WHOPIR remains on this page for three years (1), after which it is moved to the Archived WHOPIRs section.

Copies of the complete inspection reports can be requested from the relevant individual company.

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(1) As part of regulatory flexibilities taken in response to the COVID-19 pandemic, all WHOPIRs published since 2018 onwards will remain on this webpage, provided that the sites are still considered to be GMP compliant and/or that it was not replaced by a more recent WHOPIR on this webpage. Further to this, the approach is taken as a result of a significant reduction in the number of onsite inspections being performed, due to travel restrictions resulting from the COVID-19 pandemic. This regulatory flexibility will be applied until full resumption of onsite inspection activities by WHO PQT: Inspection Services and may be revoked without further notice.