See which product records need attention — right inside Shopify.
Spot missing labels and safety files across your catalog, organize the records behind your MoCRA workflow, and export structured documentation packs on demand.
- Track operational due dates for cases your team marks serious
- Exports include a manifest with versions and timestamps
- No filings, no legal advice — just clean recordkeeping
Built for
Shopify brands selling cosmetic products in the United States
Not for
Enterprise QMS, filing services, or public complaint intake
Start with one product
Install inside Shopify and build an organized product documentation record.
- 1 Sync products from your Shopify catalog.
- 2 Attach a label and supporting safety documents.
- 3 Generate a structured documentation pack.
Subscription approval and billing are handled by Shopify. The app does not submit information to the FDA.
Clean interfaces. Organized records. Clear exports.
Coverage Dashboard
Review recorded coverage gaps and operational deadlines
Templates
Start from operational checklists and printable templates
Cases
Track internal case status and operational due dates
Keep MoCRA-related records organized in Shopify
Organize product labels, supporting safety records, and adverse-event documentation in one workspace for qualified review.
Product Safety Vault
Organize labels, supporting safety records, and supplier documentation per SKU. Structured, versioned records are exportable with a manifest containing versions and timestamps.
Adverse Event Log
Internal-only workflow for product-related issues. Track case details and operational due dates for cases your team marks serious. Your team remains responsible for classification and reporting.
Structured Documentation Pack
Generate structured ZIP packages on demand. Export manifests organize file paths, versions, document types, and timestamps for qualified review.
MoCRA Profile Tracker
Record facility-registration and product-listing status, dates, and supporting documents where those requirements apply. The app does not determine applicability or file anything on your behalf.
Serious Adverse Event Documentation Pack
Package the case summary, label, attachments, and a review checklist. The app does not determine whether an event is serious, populate an FDA form, or submit a report; qualified reviewers use official FDA channels.
Organize the work before a retailer request or serious case adds pressure
2 minute read
Start a practical MoCRA records map
A practical way for Shopify cosmetic brands to map product, safety, listing, and adverse-event records without treating software as legal advice.
2 minute read
Organize product records by SKU
An operational structure for cosmetic label copies, safety substantiation records, versions, and supporting files linked to Shopify products.
3 minute read
Prepare an adverse-event documentation workflow
A careful internal workflow for cosmetic serious adverse-event records, label copies, the 15-business-day clock, and current FDA reporting instructions.
Frequently Asked Questions
Important information about what MoCRA Ops Kit does — and doesn't do.
Registration & Listing: FDA provides Cosmetics Direct and other official submission options. We only track the status you record.
Serious Adverse Events: FDA currently describes electronic and paper reporting options in its industry reporting instructions. Confirm the current method with FDA. We generate an internal documentation package; we do not submit it.
- Product Safety Vault — Organize labels and supporting safety records per SKU
- Adverse Event Log — Track case information and operational due dates for cases your team marks serious
- Structured Documentation Packs — Generate ZIP packages with export-manifest metadata
- MoCRA Profile Tracker — Record facility-registration and product-listing status where applicable, without filing on your behalf
- Serious Adverse Event Documentation Pack — Package case summaries, labels, attachments, and a review checklist
- Batch Transparency Pages (Growth+) — Publish brand-provided batch and COA information with a clear disclaimer
Ready to simplify your MoCRA recordkeeping?
Install the app to organize product records and generate exportable documentation packs from Shopify.
Install on Shopify