Field alert report (FAR)
Also called: FAR
A report US drug application holders must send the FDA within three working days of learning of certain quality problems with distributed product.
Under 21 CFR 314.81(b)(1), application holders report problems with distributed batches such as contamination, significant chemical or physical changes, or failure to meet specifications. FDA’s 2021 guidance says the clock can start when a contract lab or manufacturer learns of the problem.
Getting the information across companies quickly is most of the job.
Where it goes wrong
The lab tells the CDMO, the CDMO tells the sponsor days later, and the three working days are gone.
What Spurby does
Starts the clock from the earliest message about the result, and alerts QA and whoever files the alert.
Spurby for pharmaOn our roadmap