Glossary · Regulation & Compliance
What Is Adverse Event Reporting?
Adverse event reporting is the obligation to record, and for serious cases submit reports about, health-related events associated with a cosmetic product. Under MoCRA the responsible person must report serious adverse events to the FDA within fifteen business days, and must keep records of all adverse events for a defined period.
Why it matters when you source
Serious adverse events are the trigger that turns a quality problem into a regulatory one. The factory's batch records are what let you answer which batch, which date, which formula — so confirm that batch-level traceability backs your reporting duty.
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