Situation

A brand selling a skincare set in the U.S. received a report from a consumer of a serious allergic reaction requiring hospitalization. The team recognized the severity but didn't know about MoCRA's SAE reporting obligation, ran an internal review instead, and only reported to FDA a month later.

Problem

Hospitalization meets the SAE threshold, and the reporting deadline is 15 business days. Reporting a month later was a clear-cut delay, and FDA issued a warning letter.

Timeline

• Day 0 — consumer hospitalization reported as an SAE
• Day 15 business days — reporting deadline passes with nothing filed
• Day 30 — belatedly reported to FDA
• Afterward — FDA warning letter received, mandatory SAE-handling procedure required

Losses