FDA can ask for your tracing records. You have 48 hours.
Most companies find out whether they can answer during the recall, not before it. This audit tells you in 14 days — in writing, on your real products.
Wholesale distributors: 1 business day, not to exceed 48 hours — 21 U.S.C. §360eee-1(c)(1)(C). Dispensers: 2 business days — §360eee-1(d)(1)(D).
One phone call starts a clock you cannot pause.
A drug gets recalled. Or FDA opens an investigation into a suspect product and one of your lot numbers is on the list. Someone calls you and asks a simple question: where did this unit come from, and where did it go?
The law gives you two days to answer. The answer has to be ready inside that window.
“Our serialization system has it.”
It has the numbers. Whether it can assemble one unit's full history, across every partner who touched it, inside 48 hours is a different question — and almost nobody has tested it.
People start opening spreadsheets.
The record exists, but in pieces: your system, your supplier's portal, an emailed file, a PDF someone saved. Assembling it is a research project. The clock does not care.
You recall wider than you need to.
When you cannot say exactly which units are affected, you pull everything that might be. Good product goes in the bin because the record could not be trusted to be precise.
The grace period is over.
DSCSA is already in force. The stabilization period ended in November 2024 and FDA's exemptions have expired for every category except the smallest pharmacies. If you are a wholesale distributor or a larger dispenser, you are already inside enforcement.
There is one clock left, and it is not yours unless you are small: 27 November 2027.
We test your traceback before a regulator does.
We pick one of your real products. We ask the question a regulator would ask. Then we time you.
We pick a unit and trace it
A real product from your real inventory. We follow it back through every hand it passed through, using only the records you actually hold today.
We put a stopwatch on it
You get a number: how many hours it takes you, today, to answer the question the law gives you 48 hours to answer. Most people have never measured this.
We write down what is missing
Every gap, what it would cost to close, and how long it takes. Ranked, so you can fix the dangerous ones first and argue about the rest later.
That is the whole product. There is no platform you have to buy to get value from it, and no rip-and-replace. If your existing systems come out clean, the report says so.
$4,500. Fourteen days. Or start at $2,500.
Pay online and we start. The $4,500 Readiness Audit includes the timed traceback on a real unit. The $2,500 Readiness Report gives you the scored gap analysis and the ranked fix list in 10 business days, without the traceback. Either way you keep the report and owe us nothing further.
What happens after you book
- We confirm scope. Within one business day of booking.
- Two calls and a data pull. Our audit team works from your existing records and systems. Usually under four hours of your team’s time.
- You get the written report. In 14 days for the audit, 10 business days for the Readiness Report. You keep it and owe nothing further.
What lands on your desk
- A written gap analysis against §582 and the systems you run today.
- Your traceback time measured on a real unit, so you have a number.
- A ranked fix list with cost and timeline against each item.
- A readiness check of the serialization system or ERP you run today, as configured.
- A pilot scope for one product line, if and only if you want one.
The battery passport audit. Same fee, same fourteen days.
From 18 February 2027, EV, LMT and industrial batteries above 2 kWh placed on the EU market need a passport under Article 77. The data it needs usually sits in different systems and with different suppliers. We find out which of it you can actually produce today, and what it takes to close the rest.
What happens after you book
- We confirm scope. Within one business day of booking: which battery models, and whether you place them on the EU market as manufacturer, importer or distributor.
- Two calls and a data pull. We work from the records you and your suppliers already hold.
- You get the written report. You keep it and owe nothing further.
What lands on your desk
- A gap analysis of every Annex XIII data point for your battery category: held, held by a supplier, or missing.
- Who carries the duty. Whether you are the economic operator for each model, and what you need from suppliers outside the EU.
- A carrier check. The QR code Article 13(6) requires, and where a chip is worth adding against copies.
- A ranked fix list with cost and timeline against each item.
- Audit only: one passport built for real. We build the passport for one of your battery models from your actual data, and record every field that could not be filled and why.
Six regulations. One at a time.
DSCSA is where US pharma starts. If you sell into Europe, the same method applies to the rules that reach you there.
DSCSA
Can you trace one unit, end to end, in 48 hours? We measure it, then tell you what to fix.
Book this audit — $4,500 ↓EU FMD
Where a copied barcode would pass your checks, and what closes that hole.
Request this audit →EU Battery Passport
The first product passport with a hard date. Article 77 identity from cell to second life.
Book this audit — $4,500 ↓EU Digital Product Passport
Carrier readiness and whether the physical anchor survives the product's life.
Request this audit →EUDR Provenance
Plot-level origin and due-diligence readiness for cocoa, coffee, timber, palm, rubber and soy.
Request this audit →Something else
Forced Labour Regulation, UAE Tatmeen, or a mandate not listed here.
Request this audit →
In the field · pallet-level verification
The questions people ask before they book.
How much does the Aeroz Readiness Audit cost?
$4,500, fixed, paid online, for the full Readiness Audit in 14 days. For a lighter first step, the Readiness Report is $2,500 and comes back in 10 business days. Larger multi-regulation scopes are quoted after a short call.
What do I actually get for $4,500?
A written report in 14 days: where you are exposed under the regulation, a timed test of how fast you can trace one unit today, a fix list with costs and dates, and a scoped pilot for one product line. It is written to be handed to a regulator or a board, not to a salesperson.
How fast do I have to answer FDA?
If you are a wholesale distributor: 1 business day, not to exceed 48 hours (21 U.S.C. §360eee-1(c)(1)(C)). If you are a dispenser: 2 business days (§360eee-1(d)(1)(D)). The clock starts when the request arrives, not when you find the records.
Is DSCSA actually being enforced yet?
Yes. The stabilization period ended 27 November 2024. Manufacturer exemptions expired May 2025, wholesale distributors August 2025, larger dispensers November 2025. Only small dispensers have time left, until 27 November 2027.
Do I need TraceLink, Antares or MediLedger, or have to replace them?
No on both counts. Aeroz runs on its own, so you don't need any of them. If you already run one, we test whether the data it holds can answer a regulator's question in the time the law allows, and Aeroz can connect to it through EPCIS 2.0 rather than replace it.
Do I have to buy anything after the audit?
No. It is a standalone engagement with a written deliverable and no obligation. Plenty of people buy it purely to size their exposure and stop there. That is a legitimate outcome and we will not chase you.
What if the audit says we are fine?
Then you have a dated written record saying so, which is worth having the next time your board or a customer asks. We will not invent a gap to justify the fee, and the report says plainly what it found.
Who runs the audit and how much of my team's time does it take?
Our audit team, working from your existing records and systems. Expect two calls and a data pull — usually under four hours of your people's time across the fortnight.