For US dietary supplement brands

Your complaints are in a spreadsheet, an inbox, and someone’s memory

Supplement SafetyOps puts them in one place, shows you which ones FDA has to hear about, and counts the fifteen business days - so the decision is made by a person and the deadline is not the thing that fails.

Book a 30-minute walkthrough See how it works

No card. We use a real complaint, not a slide deck.

How a complaint moves through Supplement SafetyOps A report arrives, a person triages it, a fifteen business-day clock runs, and the decision is sealed into a record. A report arrives A person decides 15 BUS. DAYS weekends and your holidays excluded Recorded, and provable Six years later, an inspector can see what you knew and when.
15 business days to report a serious event
6 years you must keep the record
4 ways a complaint can reach you
$0 extra per case, ever

The problem

One email, and the clock is already running

A consumer emails your support inbox saying they felt dizzy after taking two capsules. That email is now a regulated record.

Which day is day zero?

Not the day someone noticed the email. The clock starts when the minimum information is known to your responsible person - and a person has to confirm that.

Is “serious” the same as “severe”?

No, and confusing them is the most common way a reportable event gets closed. They are different questions, so they are different fields.

Can you prove it in 2032?

Six years later an inspector asks what you knew and when. A spreadsheet with no history cannot answer that.

How it works

Nothing arrives as a case

Everything lands in a queue and a person decides what it is. An order is not a complaint, and a complaint is not automatically an adverse event.

  1. It arrivesThrough any of four routes, all landing in one queue.
  2. Someone triages itComplaint, adverse event, or both. Cases can hold both, because one report often is.
  3. You find what is missingAnd the app records every attempt to get it - the attempt is evidence even when it fails.
  4. A person confirms Day 0The software suggests. It never decides.
  5. Seriousness, criterion by criterionSix questions, each answered separately with its own evidence.
  6. Approval and signatureBound to one version of the record, which then locks.
Four ways a complaint reaches the system A consumer form, a forwarded support inbox, manual entry from a phone call, and a button inside a Shopify order. Consumer form A branded public page. No account needed. Support inbox Forward it. It lands in the queue. Phone or in person Written up by staff, in their words. From a Shopify order A button on the order they have open.
Four intake routes. The app also tells you which kinds of channel you have registered nothing for - those are your blind spots.
Three layers of a complaint record The original wording, what was extracted from it, and what a reviewer confirmed - kept as three separate layers. 1 · What they actually said “Took two capsules, then felt dizzy” Never edited. Never overwritten. 2 · What was extracted Product · dose · onset · symptom Each shown beside the sentence it came from. 3 · What a reviewer confirmed The version a decision was made on Signed, and then locked.
The original wording is never overwritten. Conflicting information is versioned, not replaced.

The record

Three layers, kept apart on purpose

What the person said, what was extracted from it, and what a reviewer confirmed. If those three collapse into one field, you can no longer show what you were told versus what you concluded - and that difference is the whole record.

  • Tamper-evident audit trail. Append-only and hash-chained. Editing a row breaks every hash after it.
  • Electronic signatures. Bound to a specific version, which locks.
  • Six-year retention. Including for reports never submitted, and including after you uninstall.

The distinction that matters most

A mild event can be reportable

Severity is how bad it felt. Seriousness is whether it meets a regulatory criterion. They are independent, and the pair that catches people out is top-left: something that sounded minor, and an overnight hospital admission.

The app keeps them as two fields and asks the six criteria one at a time. It does not add them up and give you an answer.

Severity and seriousness are different questions A grid showing that how bad something felt and whether it is reportable are independent - a mild-sounding event can be reportable. SEVERITY → how bad it felt SERIOUSNESS → Mild & serious A rash, and an overnight admission. REPORTABLE Severe & serious The case everyone already recognises. REPORTABLE Mild Uncomfortable, resolved on its own. Severe, not serious Distressing, and it meets no criterion.

What it looks like

A dashboard that leads with problems

Not with how well you are doing. A screen that opens with progress is a screen people stop reading.

Shopify admin › Supplement SafetyOps
The safety dashboard A dashboard that leads with overdue work and unowned cases rather than with progress. 2 cases nobody owns One owner’s account was deactivated last month 3 awaiting information 1 approaching a deadline 0 overdue Deadlines, with their working shown AE-2026-0041 4 left AE-2026-0042 11 left AE-2026-0043 14 left Every one shows which days counted, which did not, and who confirmed Day 0.

Everything else

The parts you only need once, and need badly

Quality investigations

A complaint about mould in a bottle is a 21 CFR 111 investigation whether or not anyone was hurt. One case holds both components.

Public FDA signals

Watch your brands and ingredients against public adverse-event reports and recalls. Every match is a prompt to look, never a conclusion.

Lot traceability

The product recorded on a case is what was sold at the time - not what your catalogue says today.

Manufacturer handoff

Send a structured investigation package to whoever makes your product, and track the response against your own deadline.

Roles that mean something

Administering the system and approving a decision are different powers. You cannot approve your own decision.

Inspection-ready export

Your complete archive, downloadable at any time, and emailed automatically if you ever uninstall.

Where AI stops

It suggests. You decide.

AI reads an incoming report and proposes structured fields, showing the exact sentence each one came from so you check it against the report rather than against your memory of it.

It does not decide seriousness. It does not decide reportability. It never writes to a case without a person accepting the suggestion. Where it is unsure it says so rather than guessing - a model that answers everything is more dangerous than one that declines.

What this product is not

It does not file anything with FDA, and it does not decide what is reportable. It prepares the record, shows you what the decision turns on, and keeps the evidence that you decided it. Filing and deciding stay with your qualified person, because that is where the law puts them.

It lives inside Shopify

No second dashboard, no second login. Embedded in your Shopify admin, reading products and orders and never writing to them, and shipping no code that touches your storefront or checkout.

See it on a real case

Thirty minutes. We take one complaint from arrival to a filed dossier, and you watch every decision point. Bring the case you could not decide.

Book a walkthrough Find us on the Shopify App Store

The listing is still in review, so that second link goes to the App Store itself for now. Book a walkthrough and we will tell you the moment it is live.