Glossary
Adverse Event (AE)
Any untoward medical occurrence in a person who has been given a medicine, which does not necessarily have a causal relationship with that medicine.
Details
An adverse event is something that happened to a person rather than a defect in the product, so it is distinct from a quality complaint, and it remains an adverse event even where causality has not been established. In the corpus, an outsourcing facility was cited for not submitting adverse event reports in the content and format FDA requires, for not putting a contact point for reporting adverse events on the container, and for failing to disclose serious adverse events in promotional activity. Because 21 CFR 211.198(a) requires complaint review to decide whether a complaint represents a serious and unexpected adverse drug experience, check where the complaint handling procedure connects to the safety reporting procedure.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm released and distributed multiple batches of (b)(4) that exceeded the limits for total aerobic plate count.
FDA · FDA Warning Letter · 2024-08-06 -
For example, your documented procedures for reporting adverse events do not include an adequate definition of what constitutes a “serious”…
FDA · FDA Warning Letter · 2026-05-12 -
For example, your documented procedures for reporting adverse events do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA.
FDA · FDA Warning Letter · 2021-10-26
