72.5% of Foreign Supplement Sites Were Cited by FDA: The 21 CFR 111 Specifications Canadian NHP Exporters Must Fix

A dietary supplement can pass a Health Canada site inspection and still fail an FDA one. Inspection results that ConsumerLab obtained from the United States Food and Drug Administration under the Freedom of Information Act, reported in September 2026, put a number on the gap. In the 2025 fiscal year, the FDA inspected 800 supplement manufacturing facilities and cited almost half of them for noncompliance. For sites outside the United States, the rate was far higher: 72.5 percent were cited.

For Canadian natural health product (NHP) companies that export to the United States, that number is not trivia. It is the base rate you are measured against, and it is driven by a small set of failures that repeat from one warning letter to the next. The largest is also the most preventable: companies do not establish, or do not test against, the written specifications that 21 CFR Part 111, the US current good manufacturing practice rule for dietary supplements, requires.

This article breaks down what the FY2025 data shows, why foreign sites are cited so much more often, and the exact specification and record requirements a Canadian exporter has to close before an FDA investigator, or a US importer, asks. It is the focused companion to our full 21 CFR Part 111 compliance guide for Canadian NHP exporters, zeroed in on the one failure mode that sinks the most sites.

Executive summary

The FDA's FY2025 inspection results show 800 dietary supplement facilities inspected and 49.1 percent cited, with foreign sites cited at 72.5 percent against 47.6 percent for US sites. The most frequently cited problems, consistent with the agency's own inspection history, are the failure to establish product specifications and the failure to establish or follow written quality control procedures. For Canadian NHP exporters, the fix is not another certificate. It is a documented specification system under 21 CFR 111.70, identity testing under 111.75, and the master manufacturing and batch production records that prove both. The sections below map each requirement and the practical steps to meet it.

What the FY2025 FDA inspection data shows

The results, obtained from the FDA under the Freedom of Information Act and reported in September 2026, cover 800 dietary supplement facilities inspected in fiscal year 2025. Overall, 49.1 percent received a citation of noncompliance. The split by location is the part that matters most for exporters.

The FDA inspected 720 facilities inside the United States and cited 47.6 percent of them. It inspected 80 facilities outside the United States and cited 72.5 percent. Several countries had every inspected site cited, including India, Japan, Brazil, New Zealand, Peru and Switzerland. The foreign sample is small, so treat the country figures as a signal rather than a precise probability, but the direction is unambiguous: a supplement site outside the United States is more likely to be cited than one inside it.

The FDA did not publish an FY2025 breakdown of the specific citations, so the aggregate rates above are the reliable figures. The agency's inspection history, however, has been consistent for years. The observations that top the dietary supplement list are the failure to establish product specifications and the failure to establish or follow written procedures for quality control, followed by incomplete manufacturing and batch records. Those are exactly the controls in 21 CFR 111.70 and 111.75.

Why foreign sites are cited more often

Direct answer: foreign supplement sites are cited more often for three practical reasons. They are inspected less frequently, so problems accumulate between visits. They are often built to a domestic standard, such as Canada's GUI-0158, rather than to Part 111. And the inspection is time-boxed and records-focused, which exposes any gap between written procedures and daily practice.

A Canadian site that has never mapped its quality system to Part 111 is the classic example. GUI-0158 and Part 111 overlap in principle, but Part 111 is more prescriptive on specifications, identity testing, master manufacturing and batch records, and complaint handling. A site can run a mature GUI-0158 system and still show gaps against the clauses an FDA investigator cites, because those clauses are worded differently, or in more detail, than the Canadian guidance. Our guide on Health Canada's NHP Quality Guide explains where the Canadian product-quality expectations sit, and why they are not a substitute for the US rule.

Distance also plays a role. A foreign facility may go years between FDA inspections, so a problem that a US site would have corrected after a routine visit can persist. When the inspection finally comes, the investigator reviews records first, and a system that looks fine on the floor can fail on the paper trail.

Specifications are the number one failure: 21 CFR 111.70

Direct answer: section 111.70 requires you to establish written specifications at every stage of manufacturing, for each component, for in-process points, for the finished batch, and for packaging and labels. Missing or incomplete specifications are the single most common Part 111 citation, because specifications are the yardstick. Without them, there is nothing to test a batch against, and there is no defensible basis to release it.

The finished batch specification under 111.70(e) is the classic citation. An organoleptic check, how a material looks, smells or feels, is not an identity test and cannot stand in for a numerical specification. If your Canadian file already carries a finished product specification, you are ahead, but it must be mapped to these clauses. Our article on finished product specifications for NHPs in Canada and our guide to NHP stability programmes under GUI-0158 set out the Canadian side of the same discipline.

Testing to meet specifications, and the identity-testing trap: 21 CFR 111.75

Direct answer: section 111.75 tells you how to prove a specification is met. It requires at least one appropriate test or examination to verify the identity of every component that is a dietary ingredient before you use it. For that identity test, a supplier's certificate of analysis is not enough on its own. This is the trap that catches foreign sites, because leaning on supplier paperwork feels efficient and is often how the domestic system was run.

You may rely on a supplier certificate of analysis for other component specifications, but only after you qualify the supplier. That means confirming the supplier's results with your own testing, documenting the test methods, limits and actual results, having quality control review and approve the basis, and re-confirming the certificate periodically. The identity of a dietary ingredient is the exception: you must run at least one appropriate test yourself unless the FDA grants a petition for an alternative. Finished batches must then be verified against your product specifications using a scientifically valid method, on a statistical subset or every batch. A robust supplier qualification programme is what makes a certificate defensible, and what an investigator asks to see.

The records that prove it: 111.210, 111.260 and quality control operations

Direct answer: specifications and tests only count if the records prove them. Part 111 requires a master manufacturing record for each product and batch size under 111.210, a batch production record for every batch under 111.260, and a quality control function under Subpart F that reviews and approves specifications, deviations and batch release. Missing or incomplete records are the third recurring citation, and they undo the work you did on specifications and testing.

The master manufacturing record is the approved recipe and control plan: the identity, purity, strength and composition targets, the control points, and the verification steps for each product. The batch production record is the evidence that a specific batch followed it, with the equipment used, cleaning performed, actual yields and monitoring results. The quality control unit, under sections 111.103 to 111.140, must review those records and approve or reject each batch. A specification with no batch record behind it is a claim, not a control.

What this means for Canadian NHP exporters

Direct answer: your Canadian file is a strong starting point, but it is not a Part 111 file. GUI-0158 and the NHP Quality Guide cover much of the same ground, yet Part 111 is more prescriptive on specifications, identity testing and records. Map one to the other, close the gaps, and document the result before you ship a single pallet south.

Part 111 specification and records checklist

Work this list before your next US shipment or FDA inspection. Each item maps to a Part 111 clause an investigator can cite.

• Written specifications exist for every component, in-process point, finished batch, package and label (111.70).
• Finished batch specifications use numerical limits and validated methods, not organoleptic checks alone (111.70(e)).
• The identity of every dietary ingredient is verified by at least one appropriate test (111.75(a)(1)(i)).
• A supplier qualification file supports any certificate of analysis relied on for other component specifications.
• Heavy metal, microbial and other contaminant limits are set and tested for the finished product (111.70(b)(3)).
• A master manufacturing record exists for each product and batch size (111.210).
• A batch production record is completed for every batch, with actual yields, equipment and monitoring (111.260).
• Quality control operations review and approve specifications, deviations and batch release (Subpart F).
• Product complaints are investigated and documented (111.553 and 111.560).
• FDA facility registration is current, renewed in the 1 October to 31 December even-year window, with a US Agent appointed.
• Every corrective action is backed by the record that proves it was completed.

Common mistakes

• Assuming a Health Canada site licence and GUI-0158 satisfy Part 111. They do not, and the United States has no NHP category to recognise.
• Treating a supplier certificate of analysis as identity testing for a dietary ingredient, when 111.75 requires your own test.
• Using organoleptic checks, how a material looks, smells or tastes, as finished batch identity specifications.
• Writing specifications that say meets supplier specification with no numerical limits of your own.
• Leaving contaminant limits, such as heavy metals and microbial counts, out of the finished product specification.
• Keeping a master manufacturing record but no complete batch records to prove each batch followed it.
• Describing corrective actions in a Form 483 response without submitting the evidence that proves them.
• Letting the FDA facility registration lapse by missing the even-year renewal window.

Frequently asked questions

How often does the FDA inspect foreign supplement facilities?

Less often than United States sites, which is part of why problems accumulate. In fiscal year 2025 the agency inspected 80 foreign supplement facilities against 720 US sites, and cited 72.5 percent of the foreign group. A foreign site may go years between inspections, so gaps that a domestic site would have corrected can persist until the next visit.

Why were 72.5 percent of foreign supplement sites cited?

The figure comes from FDA inspection results obtained under the Freedom of Information Act and reported in September 2026. The foreign sample is small, so read it as a signal rather than a precise probability. The drivers are consistent: sites built to a domestic GMP standard rather than to Part 111, less frequent inspection, and gaps between written procedures and daily practice.

What does the FDA cite most often in dietary supplement inspections?

The agency's inspection history consistently puts the failure to establish product specifications and the failure to establish or follow written quality control procedures at the top, followed by incomplete manufacturing and batch records. These map to sections 111.70, 111.75, Subpart F, 111.210 and 111.260.

Does a supplier certificate of analysis satisfy identity testing?

No. Section 111.75(a)(1)(i) requires at least one appropriate test to verify the identity of each dietary ingredient. You may rely on a certificate for other component specifications only after you qualify the supplier by confirming their results, documenting methods and limits, having quality control approve the basis, and re-confirming periodically.

Do Canadian NHP exporters really need to meet Part 111?

Yes. The United States regulates the product as a dietary supplement, not a natural health product, and Part 111 applies to any facility that makes, packs, labels or holds a supplement for the US market, wherever it is located. A Canadian NPN and site licence do not carry across the border.

How is a Part 111 specification different from a Canadian finished product specification?

They overlap, but Part 111 is more prescriptive. It requires specifications at the component, in-process, finished batch and packaging stages, ties ingredient identity to a mandatory test, and demands master manufacturing and batch production records that prove each batch met its specifications. A Canadian finished product specification is a strong base, but it must be mapped to these clauses.

How MFLRC can help

MF License and Regulatory Consultants helps Canadian NHP and supplement manufacturers close the exact gaps the FY2025 data exposes. We run a 21 CFR Part 111 gap assessment against your existing GUI-0158 system, rebuild finished batch specifications with numerical limits and validated methods, and set up identity testing and supplier qualification that hold up under inspection. Our quality assurance and quality control services write the master manufacturing and batch production records Part 111 expects, our audit services run mock FDA inspections so the first person to test your system is not an investigator, and our regulatory affairs, licensing and import and export team handles FDA facility registration, US Agent coordination and CAPA. See our full natural health products practice for how the pieces fit together.

Exporting supplements to the United States? Book a 21 CFR Part 111 gap assessment with MFLRC before the FDA runs one for you.

Conclusion

The 72.5 percent figure is a headline, but the story underneath it is ordinary. Foreign supplement sites are cited more often because they are inspected less, built to a different standard, and judged on records they did not keep. The fix is not exotic. Establish real specifications, test to them, prove it with the master manufacturing and batch records, and keep the evidence for every correction. Do that, and an FDA inspection becomes a formality rather than a threat. If you would like a second set of expert eyes on your Part 111 readiness, get in touch with our team.

Sources and references

• eCFR, 21 CFR Part 111, Current Good Manufacturing Practice for Dietary Supplements
• eCFR, 21 CFR 111.70, What specifications must you establish?
• eCFR, 21 CFR 111.75, What must you do to determine whether specifications are met?
• US FDA, Dietary Supplements
• FY2025 dietary supplement inspection results obtained from the FDA under the Freedom of Information Act, reported by ConsumerLab, September 2026.