FDA Warning Letters- If you have a Supplier or Customer in the USA beware.
The MHRA has reviewed its current approach to contacting UK Licence Holders who may be implicated by USFDA Warning Letters.
The IAG (Inspection Action Groups) and DMRC (Defective Medicines Report Centre) regularly receive USFDA Warning Letters and would usually contact UK Licence Holders who may be implicated e.g. in instances where a company in receipt of a letter may be a contract manufacturer or API supplier for a company who has medicines marketed in the UK.
In future the MHRA will not be contacting Licence Holders as a matter of routine and companies should ensure that they have measures in place to review and risk assess any USFDA Warning Letters. The MHRA takes the view that as these warning letters are in the public domain that all manufacturing and wholesale Licence Holders, as well as API registration holders should be reviewing these warning letters as part of their ongoing quality assessment of suppliers and contract manufacturers.
Have you got a process in place? Does your QTA with a contract manufacturer, or API supplier, who is subject to USFDA inspection, cover the responsibility of them informing you of any regulatory action they receive?
The USFDA Warning Letters are informal and advisory, they are not an indication that action is going to be taken. The company in question is able to respond to the letter, the USFAD will review the response and may re-inspect if necessary.
The full MHRA blog on FDA Warning Letters can be found here:
https://mhrainspectorate.blog.gov.uk/2025/08/08/fda-warning-letters/
Look out for our Forum on this topic.