FDA MoCRA 2026 Readiness Scorecard
The Modernization of Cosmetics Regulation Act is actively enforced. Evaluate your facility across adverse event reporting, safety substantiation dossiers, ingredient listings, and batch records in under 3 minutes.
Cosmetic Compliance Readiness Scorecard
Evaluate your brand or manufacturing facility across 8 statutory FDA MoCRA 2022 requirements. Identify immediate gaps in adverse event reporting, safety substantiation, and compounding records.
FDA Facility Registration & Biennial Renewal
Every facility that manufactures or processes cosmetics distributed in the US must register electronically with the FDA and renew registration every 2 years.
Cosmetic Product Listing & Ingredient Disclosures
Responsible persons must submit listing for each cosmetic product, including category, facility FEI where manufactured, and complete list of ingredients (including fragrances, colors, and preservatives).
Mandatory Serious Adverse Event (SAE) 15-Day Reporting
Must submit report of any serious adverse event (death, disfigurement, hospital admission, infection, disability) to FDA within 15 business days, plus keep consumer records for 6 years (3 years for small business).
Adequate Safety Substantiation Dossiers
Responsible person must maintain scientific evidence substantiating product safety before commercial distribution (toxicological profiles, patch tests, stability tests).
Preservative Efficacy & Accelerated Stability Testing
Must establish preservative challenge effectiveness and formula physical stability across elevated temperature and humidity conditions before release.
Fragrance Allergen Labeling & Artwork Proofing
Labels must disclose fragrance allergens and provide contact information for adverse event reporting (US address, phone number, or electronic contact).
Compounding Batch Records & Cleanliness Logbooks
Maintain written procedures, batch compounding records with raw lot reconciliation, equipment sanitization logbooks, and hold time tracking.
Mandatory FDA Recall Authority & Rapid Lot Tracing
FDA has statutory authority to mandate immediate recall if a cosmetic causes serious adverse health consequences. Facilities must prove 2-hour lot trace capability.
Ready to Close Your MoCRA Compliance Gaps in 4 Weeks?
Deploy Novaqis for Cosmetics with pre-configured adverse event workflows, preservative efficacy worksheets in LIMS, and compounding batch records with flat site licensing ($0 per-seat tax).