Key obligations

• Confirm the responsible person, covered facilities, and SKUs—including any small-business exemptions or carve-outs.
• Document the core MoCRA pillars: facility registration, product listing, safety substantiation, serious adverse event reporting, and compliant labeling.
• Align suppliers and contract manufacturers with quality agreements and GMP readiness ahead of FDA rulemaking.
• Publish complaint intake, escalation, and recall playbooks so teams can act within statutory windows.
• Track emerging FDA rulemaking (fragrance allergens, talc testing, PFAS reporting) and weave milestones into the compliance roadmap.

Evidence regulators expect to see

• MoCRA readiness roadmap that assigns owners, deadlines, and status checkpoints.
• Centralized library of SOPs, safety files, complaint logs, and training assets leadership can review on demand.
• Supplier questionnaires and agreements documenting allergen controls, talc validation, and PFAS disclosures.
• Training calendar and communication scripts covering adverse event intake, inspections, and recalls.

Intake sections that populate this section

• Get Started
• Company
• Adverse Event Ops
• Recall Preparedness
• Regulatory Monitoring

Relevant SOP templates

• Regulatory Monitoring & Change Control SOP
• Supplier Oversight SOP
• Training & Documentation SOP

Risk of non-compliance

• Fragmented ownership slows FDA responses and weakens retailer and investor confidence.
• Missing a unified program charter leads to inconsistent filings, opening the door to warning letters, suspended registrations, or recalls.
• Lack of supplier alignment exposes GMP gaps that derail launches during audits.

Further reading

• FDA MoCRA Landing Page
• MoCRA Statute (H.R. 2617)
• FDA MoCRA Timeline