Separate registration and listing work from label review

Build a product and facility record first

1. Identify each facility and activity: record where manufacturing or processing occurs and who controls the relevant information.
2. Identify the responsible person: connect the marketed product, label name, business details, and contact process to the entity shown on the label.
3. Map each marketed product: freeze the product name, category, formulation references, manufacturing facilities, and current label version used for listing analysis.
4. Review exemptions and deadlines: evaluate the current statutory and FDA conditions against actual size, activity, product, and facility facts rather than selecting an exemption from a checklist.
5. Maintain safety substantiation: preserve the records supporting adequate substantiation of safety and the assumptions used for the marketed conditions of use.
6. Operate the adverse-event process: retain intake, escalation, label contact, serious adverse-event reporting, and recordkeeping procedures.
7. Control changes: determine when product, facility, responsible-person, or label changes require an update and document completion.

What the label contributes

The label helps identify the marketed product, responsible person, contact channel, ingredient declaration, warnings, directions, and claims. It does not by itself prove a valid facility registration, product listing, exemption, safety record, or adverse-event submission. Keep identifiers and versions aligned across the label, internal product record, and any FDA submission workflow.

Official starting points

• FDA MoCRA overview
• FDA Cosmetic Facility Registration and Product Listing
• FDA serious adverse-event reporting

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