Find out what the warehouse audit will say, before the auditor does.
Send us your procedures, your qualification packages, and a sample of your records. We read the whole scheme against all of it and tell you what is wrong, while there is still time to fix it.
Warehouses get judged on paperwork they were never asked to keep. More than a third of this scheme cannot be answered by any document at all — it is about the building and what people are seen doing in it.
The scheme behind “we need your warehouse registered.”
It is what a warehouse or distribution center is audited against when a supplement brand, a contract manufacturer or a marketplace asks for GMP registration on the storage and shipping end of their supply chain.
It covers dietary supplements, dietary ingredients, raw materials, and packaging and labeling materials. And it is not the same document a manufacturing plant is audited against — a warehouse has its own scheme, with its own requirements, and being registered for one does not register you for the other.
The trouble is that the people running a warehouse well did not come up through quality. They move pallets, they hit their windows, they keep the building clean. This scheme asks them for a filing cabinet nobody ever told them to build.
Most of it has nothing to do with storing product correctly.
These are requirements a well-run distribution operation routinely does not have, because no customer ever asked for them until this one did.
A valid Bioterrorism registration number, a Unique Facility Identifier, and evidence the registration is current. Checked, not assumed.
Roles and back-ups named, provisions for photographs, video and sample collection, records of every notification received, and written responses with corrective actions.
A procedure for telling affected customers and NSF about a regulatory citation, with records of the communication and evidence the correction was made.
A food safety event requiring public notification has to reach affected customers and NSF in writing inside a day.
A written procedure for visitors, contractors and non-site personnel covering access, GMP awareness, dress code and identification — and a visitor log that is actually maintained.
Supplements, dietary ingredients, raw materials, and packaging and labeling materials are all in scope, so the controls have to cover all of them, not just finished goods.
None of that is about whether you store product properly. All of it is auditable, and every one of them is a finding if it is not there. A site can run spotless racking, perfect temperature records and flawless FIFO, and still be written up on all six.
NSF GMP Warehouse and Distribution System Assessment
We read the whole scheme against your system, tell you what is wrong with it, and tell you what to fix first.
And it is built to survive more than one auditor’s reading. This is not one person forming an opinion about your system. Every clause is examined against the documents meant to answer it, the records meant to prove it, the technical discipline behind it, and everything elsewhere in your system that could contradict it. Those reads are made independently and then reconciled into one answer, so forty findings that all come from one missing control arrive as one problem with every affected clause attached.
The registration auditor still decides. They simply have far less left to work out for themselves.
What this covers
- Whether what you have already written is good enough, requirement by requirement
- Which of your documents answers which requirement, and where inside it
- Whether your FDA registration actually stands up to the four checks the scheme makes on it
- Whether the procedures this scheme wants exist at all, or were never written because nobody asked
- What an auditor would write up, and the exact thing that would close it
- Which requirements no document can answer, because they are about the building or about what people do
- What to fix first, so you do not do the same work twice
What you get back
Every requirement of the scheme, in the order it puts them, marked answered or not. Where one of your documents answers it, we name the document and the page. Where nothing does, we say so and leave it blank.
Then the things that are not simply missing. What is there but does not go far enough. What one of your documents says that another one contradicts. What a procedure claims happens that your records do not show happening.
When forty findings all come from one missing procedure, we write it once and point the rest at it. You get the cause, not the pile.
And we tell you what to fix first. Every entry names the thing that is absent: the evidence, the decision, or the document. Not how to run your building.
You get the assessment, and a workbook listing every requirement against the document that answers it. Hand that one straight to the auditor.
What you send
Your procedures and controlled documents, your qualification packages, and a sample of your records. We tell you which records and which dates, so you are not guessing and you are not uploading the whole file room.
Five business days, from the day we confirm we have everything. If something important is missing, you hear about it before the clock starts.
What this catches
A well-run distribution center with a clean history, read against this scheme. The company is made up. The rules underneath are real and you can look every one of them up.
Nobody has ever inspected the place, so nobody wrote the procedure.
A site that has never had a regulatory visit. No citations, no warning letters, no notifications of any kind on file.
There is no procedure for what happens when someone does turn up. Nobody is named, nobody has a back-up, and nothing says whether an investigator may photograph the racking or take a sample.
Clause A.1.3 wants that procedure written and its records kept — roles and back-ups defined, provisions for photographs, video and sample collection, a record of every regulatory notification received, and written responses with corrective actions. A clean history is not evidence of the procedure. It is the reason the procedure never got written.
The badge system is excellent. There is no visitor log.
Electronic access control on every door, badges issued and revoked properly, contractors escorted.
Nothing written says what a visitor is told before they walk in — no dress code, no GMP awareness, no identification rule — and there is no visitor log at all, because the badge reader was treated as the record.
Clause A.1.5 wants access controlled and wants a written procedure covering visitors, contractors and non-site personnel: control of access, GMP awareness and dress code, and visitor identification. A.1.5.2 then wants a visitor log maintained on top of it. A door that logs badges answers neither.
A registration certificate that does not match the building.
An FDA facility registration on file, printed and in the binder, with a valid-looking number on it.
The address on it is the corporate office, not the warehouse. Nobody has checked the expiry date in three years.
Clause A.1.2 asks for the Bioterrorism registration number and the Unique Facility Identifier, and it asks for evidence the facility — this building — is registered. A registration held at the wrong address does not cover the site being audited, and it is the kind of thing nobody looks at until an auditor asks for it on the morning.
Made-up company, real rules. We write these to show you the kind of thing that gets found, not to claim we found it. Your assessment is written against your own documents.
Price
What actually lands on your desk.
Four pieces of a finished assessment, opened here on the page. They come out of one written against a company we invented and read against NSF/ANSI 455-2, so you can see the shape of the thing before you pay for it. The company, its documents and its records do not exist. The requirements underneath are the real, published requirements of that standard.
Cascade Nutraceuticals is invented, and so are its documents and its records. They were written to show what the deliverable looks like, not to claim a catch. This specimen is an assessment against NSF/ANSI 455-2, not against the NSF GMP Warehouse and Distribution registration requirements: what changes from one scheme to the next is the standard behind the read, not the shape of what comes back. The requirements it is read against are the real, published requirements of NSF/ANSI 455-2. The standard’s own wording is not reproduced here; the clause identifiers and the federal citations are.
Every requirement of NSF/ANSI 455-2-2024, in the standard’s own clause order, with how it is answered, what that rests on and where inside it, and any finding against it. Five of the 695 rows.
The delivered workbook carries each requirement in the standard’s own wording. That wording is not ours to publish, so what you read below is our paraphrase of it. The clause identifiers and the federal citations are the standard’s own.
| Clause | The requirement, paraphrased | How it is answered | What that rests on, and where inside it | Finding |
|---|---|---|---|---|
| 4.1.1 | Whoever holds quality responsibility is not the post that runs operations. [21 CFR 111.12(b)] | Not found in what was supplied | Read against OOS-24-007 signature line, HR-TRN-01 “Competency by Function” first row, and LAB-2403-118 “Review & Approval”. Each of the three records the quality post and the operations or analyst post as one post; none establishes the separation the requirement calls for, and no organization chart, written assignment or delegation record was supplied. | 4.1.1 |
| 4.1.2 | The quality control work is identified, and it is carried out. [21 CFR 111.65] | Addressed, not settled from what was supplied | SOP-QC-012 §3.0 identifies the quality control duties, and OOS-24-007 and LAB-2403-118 record those duties being exercised on two lots. What was supplied does not reach whether quality control operations are implemented across manufacturing, packaging, labeling and holding: no batch production record, master manufacturing record or packaging and labeling record arrived, and none was declared as not existing. | No finding |
| 4.2.1 | Written procedures set out what quality control is responsible for. [21 CFR 111.87, 111.103, 111.105, 111.140(b)(1)] | Evidenced, no finding | SOP-QC-012 §3.0 Responsibilities. | No finding |
| 4.4.19 | Sewage and waste are plumbed away from the plant so they cannot reach contact surfaces, product, components or the water supply. [21 CFR 111.15(g)] | No document can answer it | Named at the front, under what documents could not answer. It turns on how the building is plumbed, which nothing you could send can settle, and no directed remote observation was purchased. It carries no finding. | No finding |
| 4.6.15 | Quality sets and approves the laboratory controls, including the sampling plans, how specifications are set, the test methods and the reference standards, and those methods are used to the criteria set for them. [21 CFR 111.315] | Evidenced, with a finding | LAB-2403-118, “Reference Standards & Reagents”; “System Suitability”. | 4.6.15 |
Eight dispositions run down that third column and every one of the 695 rows carries one. “Not found in what was supplied” says nothing was found in what was examined. It never says the control does not exist in your operation.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Every document supplied and what each one points at, built from the same references the drawn map in the assessment is built from. Fourteen documents arrived.
| Your document | What it references | Was the reference supplied | What points at it | How many point at it |
|---|---|---|---|---|
| SOP-QC-012 | FORM-QC-12A; FORM-QC-12B; SOP-QA-005; SOP-QC-002 | None supplied | OOS-24-007; HR-TRN-01 | 2 |
| MV-RHO/ASH-01 | ASSAY-RHO/ASH-01 Rev. 0; SOP-QC-002 | None supplied | Nothing points at it, and nothing has to | 0 |
| LAB-WS-007 | ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx; LAB-2403-118 | LAB-2403-118 supplied; ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx not supplied | Nothing points at it, and something has to | 0 |
| LAB-2403-118 | ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx | None supplied | LAB-WS-007 | 1 |
| OOS-24-007 | SOP-QC-012; CA-24-006 | SOP-QC-012 supplied; CA-24-006 not supplied | Nothing points at it, and nothing has to | 0 |
| QC-RSV-01 | Record-retention SOP | None supplied | CMP-LOG-AS | 1 |
| HR-TRN-01 | SOP-QC-012; Record-retention SOP | SOP-QC-012 supplied; Record-retention SOP not supplied | Nothing points at it, and something has to | 0 |
| SQF-RHO-03 | Supplier certificates of analysis; RM-RHO | None supplied | Nothing points at it, and nothing has to | 0 |
| REG-CLM-AS500 | AS-LBL Rev. 3 (2023); Ingredient supplier monographs | None supplied | Nothing points at it, and something has to | 0 |
| CMP-LOG-AS | QC-RSV-01 | Supplied | Nothing points at it, and something has to | 0 |
| PDC-AS700-01 | MBR-AS700; MF-AS700 rev A; SOP-VAL-02; CC-25-031 | None supplied | Nothing points at it, and nothing has to | 0 |
| CWC-SQCA-220 | CWC-SCA | Supplied | CWC-SCA | 1 |
| CWC-SCA | CWC-SQCA-220 | Supplied | CWC-SQCA-220 | 1 |
| NNRG-SQ-014 | No document named | No reference to check | Nothing points at it, and nothing has to | 0 |
Sixteen of the twenty-one documents this set names were not themselves supplied. They get their own sheet in the workbook, and that is the sheet worked first: it is the shortest route to closing the largest number of open rows on the requirement map.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Each finding is headed by the requirement it rests on and a short name for what is at issue. Findings sit in the standard’s own clause order, under the group stating what the assessment established about your record, and each one closes on the consequence that follows from it. This is one of eleven.
The delivered assessment heads the finding with the requirement in the standard’s own wording. That wording is not ours to publish, so the requirement line below is our paraphrase of it.
The release result reported for lot AS4830922 was not calculated against a reference standard that was within the expiry the record itself states for it.
LAB-2403-118, “Reference Standards & Reagents” table: the Rosavin reference standard, lot R04219, carries an expiry of 30 NOV 2023. The same report records the run as acquired 11 MAR 2024 and the reportable result as calculated from the bracketing Rosavin standard mean.
LAB-WS-007 for the same lot repeats the standard lot as R04219 and the reference-standard expiry as 11/30/23, and records the reportable value as transcribed from a spreadsheet named in the worksheet rather than calculated on the worksheet.
LAB-2403-118, “System Suitability”: the replicate-standard %RSD is entered as “not calculated” and the suitability acceptance criterion is entered as “per method file”, so the record carries no criterion the standard was judged against on the day of the run.
The reference standard is what the result is measured against; where its expiry has passed, the number the lot was released on has nothing established behind it.
What was supplied does not establish a supportable result for the release of lot AS4830922.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
One row per finding, in the standard’s own clause order. Eleven rows. This is one of them.
The delivered register carries the requirement in the standard’s own wording. That wording is not ours to publish, so the requirement cell below, and the one place another cell restates a clause, are our paraphrase.
QC-RSV-01, “Reserve Sample Records”, the row for lot AS4815602 (manufactured 11/2023, expiring 11/2026): the units retained column reads “none on file”, and the container, retain-until, storage and logged-by columns are each empty.
QC-RSV-01 is the only record supplied that addresses reserve sample collection; its header states the retention policy as written rather than referring to a procedure, and names no procedure that governs it.
Everything under “Yours to fill” is yours, and it is delivered empty. No owner is assigned, no date is set and no status is pre-filled, because each of those needs to know what your operation can absorb and nothing in this assessment knows that. There is no formula in the file, so you can add columns, add rows and set your own filters without breaking it.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Straight answers.
You never see my building. What is the point?
We read every requirement. The ones that are about the building, or about what people physically do, get named as exactly that and get no finding. The rest can be answered from what you send. On this scheme that split matters more than most — 106 of 276 need the building, so the walkthrough is worth more here than it is elsewhere.
We store product, we do not make it. Is this really for us?
Yes, and that is the point. A warehouse has its own scheme with its own requirements, and being registered against a manufacturing scheme does not cover you. Most of what this one asks for is administrative rather than operational, which is exactly why well-run sites get caught out.
Can I just download the checklist?
You can, and it will tell you the clauses exist. It will not open your visitor procedure and tell you the clause is still unanswered. Having a document is not the same as having one that answers the requirement.
What if you find something we cannot fix in time?
Then you know before the auditor does, and you get to decide what to do about it. That is the point of the name. We lay out what is there and what would close it; which risks you carry into the audit is yours to choose.
Our audit is not booked yet. Is this useful now?
That is the better time for it. Getting on a schedule takes months, and once a date is set it costs to move it. Everything this finds is work you would rather be doing before there is a date at all.
Is what I send confidential?
Yes. What you send is used only to do the work you paid for, seen only by the people doing it, never sold, and never used to train any public AI model. It is kept only as long as we need it. Section 4 of the privacy policy, linked at the foot of every page.
This page is about one scheme. You may need something else.
An assessment reads your whole system and tells you what is wrong with it. If that is not the job in front of you, here is where the rest of the work goes.
Regulatory work product, not legal advice. An assessment is prepared from the records you submit and is not legal counsel, not a registration decision, and not a prediction of any audit outcome — those are decided by the certification body. It is a read of documents: no site visit is performed, and every requirement that depends on physical conditions or observed practice is named as outside the read and gets no finding unless the optional facility walkthrough is purchased, in which case each such finding states what was shown, by whom, and on what date. It relies on what you supplied and on your own declarations about your operation, none of it independently verified. Clause references are quoted from NSF’s GMP Warehouse and Distribution registration requirements. All companies and products shown in examples are constructed; any resemblance to a real company or product is coincidental. Regulatory Options is not affiliated with or endorsed by NSF.