MHRA on FDA Warning Letters

In a blog posted on 8 August 2025, MHRA’s Chris Jones (IAG Chair) and Himal Makwana (Head of DMRC) elaborates actions UK licence holders should take following issuance of USFDA Warning Letters to their supply chain partners.

UK licence holders who may be implicated because of a Warning letter to their contract manufacturer or API supplier, should ensure they have measures in place to review and risk assess USFDA Warning Letters and other regulatory actions. They shall notify MHRA via DMRC if the risk assessment shows a need to notify. USFDA Warning letters (and other regulatory actions like Official Action Indicated (OAI), and Import Alerts) are in public domain and MHRA expects that all license holders and API registration holders should be reviewing these letters as part of their supplier quality assessment programmes. The UK license holders and registrants should have robust technical agreements with the suppliers to ensure prompt communication of such actions. MHRA may not be contacting licence holders as a matter of routine.

MHRA’s Inspection Action Groups (IAG) are responsible for recommending and implementing regulatory action against companies for breaches across all GxPs.

FDA Warning Letters (MHRA Blog)