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More information11th August 2025
MHRA Blog - FDA Warning Letters
FDA Warning Letters: What UK Licence Holders Need to Know The MHRA's Inspection Action Groups (IAG) and Defective Medicines Report Centre (DMRC) have highlighted the importance for UK manufacturers, wholesalers, and API suppliers to proactively review US FDA Warning Letters. These letters, which are publicly available, should be considered as part of routine supplier qualification and risk assessment processes. Going forward, the MHRA will not routinely contact licence holders about these letters; instead, companies are expected to monitor and assess them independently. If any concerns arise that may affect UK medicines, notifications should be made to the MHRA via the DMRC or IAG.
For more information, visit the full blog post: https://mhrainspectorate.blog.gov.uk/2025/08/08/fda-warning-letters/