For supplement makers asked to get NSF/ANSI 455-2 certified
See what your auditor will find, before the audit.
Send us your procedures, validation packages and a sample of your records, then walk us through the plant on a video call. We check every requirement in NSF/ANSI 455-2 and tell you exactly what is missing, what would close it, and what to fix first.
- What the standard asks for
- A traceability and mock recall exercise at least once a year, traced forward and back, recovering 99.5% to 101.5% of the product within four hours.
- What your documents show
- A recall procedure and one mock recall from 2023. It records no recovery figure and no time.
- Status
- Not answered
- What would close it
- A yearly exercise, traced both ways, with the recovery and the time written down.
Five business dayscounted from when we have everything
Every requirementin the standard, read against your own documents
Video walkthrough includedyour people show us the plant, nobody travels
FDA keeps finding gaps under the federal rule this is built on.
Source: FDA’s published inspection classification and citation data, fiscal years 2009 to 2026, counted by Regulatory Options. These are observations FDA investigators wrote down. They say nothing about any one plant.
FDA being happy with you is not the same as passing 455-2.
The standard is built on 21 CFR Part 111, then adds what retailers asked for on top (clause 1.2). Plants that have never had trouble with FDA get caught on the extras.
A written recall plan
Steps to take and who takes them. Part 111 never asked a supplement plant for one.
Clause 4.6.19A yearly traceability exercise
Forward and back, 99.5% to 101.5% of product recovered, inside four hours.
Clause 4.6.20Environmental monitoring
A risk-based program for microorganisms in your production areas and on your equipment.
Clause 4.5.84None of these three has a counterpart in 21 CFR Part 111.
How it works
- 1
Send your documents
Procedures, qualification and validation packages, and a sample of records. We tell you which records and which dates, so you are not guessing.
- 2
Walk us through the plant
A video call of three to four hours. Your people hold the camera, we tell them what to show and ask the questions. We don’t record it.
- 3
Get your gap list
Five business days after we confirm we have everything. If something important is missing, we tell you before the clock starts.
What you get back
Every requirement of the standard, checked and accounted for. No row left blank.
- Your findingsEach gap, what it rests on, and what would close it. Forty findings from one missing procedure are written once, as one cause.
- What to fix firstAn order to work in, so you fix the procedure before you rewrite a year of records.
- A map of every requirementWhich of your documents answers it and where, or that nothing does.
- A map of your own documentsHow your procedures point to each other, so contradictions show.
| Clause | What it asks for | Answered by | Status |
|---|---|---|---|
| 4.3.1 | Risk-based supplier qualification for every ingredient | SOP-PUR-004, section 5 | Partly answered |
| 4.5.84 | Environmental monitoring of production areas and equipment | Nothing you sent | Not answered |
| 4.6.19 | Written recall plan with steps and who takes them | SOP-QA-021 | Answered |
| 4.6.20 | Yearly traceability exercise, 99.5% to 101.5% in four hours | Mock recall record, 2023 | Not answered |
| 4.5.2 | Precautions against contamination | Video walkthrough | From the walkthrough |
Made-up plant, real clauses. Each requirement is described in plain words with its clause number; we never copy the standard’s text.
Where clean-running plants get caught
Three years of certificates, and no supplier decision anywhere.
A certificate on file for every lot. But nothing records who approved each supplier, on what basis, or when that is looked at again. The standard wants a risk-based qualification program for every ingredient, with requalification.
Clauses 4.3.1, 4.3.2A recall procedure that has never been tested the way the standard tests it.
The procedure exists. The one mock recall on file gives no recovery figure and no time, so it cannot show the 99.5% to 101.5% within four hours the standard asks for.
Clause 4.6.20Corrective actions, but no preventive ones.
Every out-of-spec result has a corrective action. The standard wants a corrective and preventive action program for every nonconformance, not only failed specifications.
Clause 4.7.2Made-up company, real rules. These show the kind of thing that gets found. Your assessment is written against your own documents.
What your other options cost
| Option | What it costs | What you end up knowing |
|---|---|---|
| Wait for the audit | Certification audit fees of $5,000 to $20,000 per facility | What is missing, once it is on the audit report |
| Download a checklist | Little or nothing | That the requirements exist, not whether your documents meet them |
| Hire a consultant for a gap assessment | Commonly $5,000 to $15,000, plus travel | Their findings, after days on your floor |
| This assessment | $7,000 fixed. No travel. | Every requirement of NSF/ANSI 455-2 checked against your documents and a video walkthrough, back in five business days from when we have everything |
Audit fees and consultant range: a published consultant planning guide, as reported by BSCG in 2026.
One price. Everything included.
NSF/ANSI 455-2 System Assessment
- Every requirement in NSF/ANSI 455-2 read against what you send
- A directed video walkthrough of your plant, three to four hours
- Every finding, with what would close it
- What to fix first
- A requirement map and a document map
- A workbook with all of it, in the standard’s clause order
One assessment covers one site. All purchases are final. Fees are non-refundable once we begin work on your order — for a service, when you submit the records we request. Terms of Service.
Want someone on site instead? That is consulting, quoted separately. Ask about consulting.
Questions people ask first
We already have FDA compliance and supplier COAs. Doesn’t that count?
It counts for what it covers. Part 111 is the floor this standard is built on (clause 1.2). On top of it, the standard asks for a written recall plan, yearly traceability exercises, environmental monitoring, qualified suppliers for every ingredient and a corrective and preventive action program. We read what you have against all of it and tell you what it answers and what it doesn’t.
You never see my plant. What is the point?
We see what your people show us. Every assessment includes a video walkthrough. Your people walk the plant while we tell them what to show and ask the questions. What they show gets answered, with findings. What they don’t show stays unanswered.
How long does it take? We have a deadline.
Five business days, counted from the day we confirm we have everything. We tell you exactly which records and dates to send. If something important is missing, we tell you before the clock starts.
Is anything extra?
No. $7,000 covers the full read, the video walkthrough, the findings, both maps and the workbook. Nobody travels, so there is no travel to pay. If you want someone on site, that is consulting, quoted separately.
We have more than one site.
One assessment covers one site. If you have more than one site, buy one for each.
Will you tell me what grade I’ll get?
No. Nobody honestly can. How each finding is classified is the auditor’s judgment (clause 5.5.9), and a reviewer at the certification body checks it (clause 5.6.2). What we tell you first is which requirements your system doesn’t answer.
Is what I send confidential?
Yes. We use it only to do the work you paid for, only the people doing that work see it, we never sell it, and we never use it to train any public AI model. We keep it only as long as we need to deliver the work and meet our record obligations.
Know what the auditor will find while there is still time to fix it.
$7,000, one site, back in five business days from when we have everything.
Regulatory Options is not affiliated with NSF or endorsed by it. This is not legal advice and not a certification decision. We don’t grade your operation, predict your audit or fix anything.
Example companies on this page are made up. The rules they are read against are real.
Not the right fit? See every assessment or ask about consulting.