Axentra runs the post-market safety process for cosmetic brands: adverse-event intake, serious-event assessment, FDA Form 3500A preparation, and communications for the Responsible Person. Work is quoted per project. This is not FDA approval of the cosmetic.

​

WHO THIS IS FOR

​

Responsible Persons for cosmetics sold in the United States — including foreign brands whose name appears on the label  who need a documented MoCRA-compliant adverse event process before the first complaint arrives. Day 0 of the statutory clock is the date the Responsible Person receives the information, not the date Axentra is engaged.

​

WHAT MOCRA REQUIRES

​

Under MoCRA, the Responsible Person must:

• Report serious adverse events to FDA within 15 business days of becoming aware

• Submit material new information received within one year of the initial report as a follow-up

• Keep records of all adverse events — serious and non-serious — for six years

 Produce those records on FDA request during inspection

​

Seriousness is assessed against the statutory limbs (including hospitalization, infection, and significant disfigurement). Which limb applies matters — it is not enough to mark a case "serious" without documenting why.

​

HOW AXENTRA WORKS

​

1. Intake — Capture reports from consumer contact channels (email, phone, web form, retailer, distributor) into one case record.

2. Seriousness assessment — Evaluate each report against MoCRA's seriousness limbs and document the rationale while the facts are fresh.

3. Causality and recommendation — Assess relatedness, record written reasoning, and recommend whether the case is reportable.

4. FDA reporting — Prepare Form 3500A and supporting materials for the Responsible Person's filing within the 15-business-day window.

5. Recordkeeping — Maintain audit-ready files for the six-year retention duty. Cases and attachments are never deleted.

​

WHAT YOU RECEIVE

​

• Documented intake and triage workflow

• Seriousness and causality assessment with written reasoning

• FDA Form 3500A field map and filing support

• Six-year record retention format ready for inspection

• Project quote before work starts

​

FREQUENTLY ASKED QUESTIONS

​

Q: What is cosmetovigilance under MoCRA?

A: Cosmetovigilance is the post-market safety process for cosmetics: receiving consumer adverse event reports, assessing whether an event is serious, documenting all events, and reporting serious adverse events to FDA within 15 business days.

​

Q: Who must report serious adverse events for cosmetics?

A: The Responsible Person — the manufacturer, packer, or distributor named on the product label — must report serious adverse events to FDA. Foreign brands that appear on the label as the Responsible Person are fully subject to this obligation.

​

Q: How quickly must a serious adverse event be reported to FDA?

A: Within 15 business days of the Responsible Person receiving information about the event. Day 0 is the date the Responsible Person became aware, not the date a consultant was hired.

​

Q: What counts as a serious adverse event for cosmetics?

A: An event associated with use of the cosmetic that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, or significant disfigurement (including serious and persistent rashes), or that requires medical or surgical intervention to prevent one of those outcomes.

​

Q: Must non-serious adverse events be kept on file?

A: Yes. MoCRA requires records of all adverse events — serious and non-serious — to be retained for six years and made available to FDA on request.

​

Q: What does Axentra's cosmetovigilance service include?

A: Axentra runs adverse-event intake, seriousness assessment against the statutory limbs, FDA Form 3500A preparation and communications for the Responsible Person, and audit-ready recordkeeping. Work is quoted per project and is not FDA approval of the cosmetic.

​

READY TO SET UP YOUR SAE PROCESS?

​

Email info@axentracompliance.com or call +1 505-358-4858. Based in Albuquerque, New Mexico.