MoCRA Checklist

• Facility registration

  Your facility (or your contract manufacturer’s) is registered with the FDA.

• Product listing

  Each product and each formula variant is listed with the FDA, with ingredients.

• Safety file

  Each product has safety substantiation evidence kept on file.

• Adverse events

  You have a system to record adverse events and report serious ones to the FDA within 15 business days.

• Labeling

  Your label carries the responsible person contact and you meet the labeling rules in force.

• Good Manufacturing Practices

  Your GMP records are aligned with FDA expectations.

• California extras

  You completed Prop 65 screening and reviewed the Toxic-Free Cosmetics Act bans if you sell in California.

This checklist is general information, not legal advice. Confirm requirements with a regulatory attorney or consultant. — Cosmetics.com.AI, Know What You Wear.