Complaint log
Adverse Event Log for Cosmetic Sellers
A complaint log helps you connect what the customer reported to the product, batch, label, lot code, photos, medical follow-up, and escalation status.
Quick answer: FDA says responsible persons must report serious adverse events associated with cosmetic products in the United States within 15 business days and include a copy of the product label. FDA also says new medical or other information received within 1 year of the initial report must be submitted within 15 business days. A small seller should log every safety complaint promptly, then escalate serious-event questions for qualified review.
Record the report date, customer description, product, lot code, and contact channel.
Attach label version, batch record, photos, supplier lots, and order details.
Mark medical care, infection, significant rash, burns, hair loss, or disability concerns.
Move serious-event questions to qualified review and track follow-up.
Fields to include
- Complaint ID, date received, source, and customer contact details.
- Product ID, product name, variant, batch ID, lot code, order number, and sales channel.
- Customer description, timing, symptoms, photos, and product use details.
- Label version, ingredient lots, packaging lots, and supplier records connected to the batch.
- Medical attention, hospitalization, infection, significant rash, burns, hair loss, or disfigurement flags.
- Initial serious-event report date, if any, new-information received date, supplemental due date, and label-copy status.
- Escalation owner, professional review status, follow-up date, and resolution notes.
Serious-event flags to escalate
FDA's adverse-event update describes serious adverse-event categories including death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, and significant disfigurement such as serious persistent rashes, second- or third-degree burns, significant hair loss, or persistent significant alteration of appearance.
Do not wait for a perfect spreadsheet before escalating a serious concern. The log exists so facts are visible quickly.
FAQ
Should I log minor complaints?
Yes. Minor complaints can reveal batch, label, supplier, or formulation patterns. Use a calm intake process for all product complaints.
Does the log decide whether a report is serious?
No. It organizes facts and flags issues for review. Serious-event determinations should be made with current FDA sources and qualified help when needed.
Why attach the label version?
FDA says serious adverse-event reports include a copy of the label. The label version also helps you investigate directions, warnings, ingredients, and contact information.