Key obligations

• Log every complaint from consumers, retailers, health-care providers, and social media.
• Escalate potential serious cases to a medical reviewer the day they arrive.
• Submit FDA Form 3500A (with a label image) for each confirmed serious adverse event within the 15-day window.
• Send follow-up reports when new medical information arrives within one year.

Evidence regulators expect to see

• Complaint intake log showing timestamps, severity, and actions.
• Escalation ladder that names medical reviewers and regulatory approvers.
• Copies of FDA submissions and acknowledgement emails.
• Retention proof that complaint files stay on record for at least 6 years (3 for small businesses).

Intake sections that populate this section

• Adverse Event Ops
• Primary Contacts
• Records Access

Relevant SOP templates

• Serious Adverse Event SOP

Risk of non-compliance

• FDA warning letters for late or missing submissions.
• Civil penalties or injunctions if serious events stay unreported.
• Retailer penalties and loss of shelf space during investigations.

Further reading

• 21 U.S.C. § 364a – Adverse events
• FDA: How to Report a Cosmetic Product Complaint