FSVP Records US Importers Need for India

Direct Answer: A US importer’s FSVP file depends on the product. Dietary supplement ingredients follow 21 CFR 1.511 in three tiers, and none requires a hazard analysis. Botanicals sold as ordinary food follow the full program: hazard analysis, supplier evaluation, verification and corrective action. Records are kept at least two years and must be retrievable within 24 hours.

The Foreign Supplier Verification Program (FSVP) is a duty of the US importer, not of the Indian supplier. But the importer’s file is built largely from documents that only the supplier can provide, so a supplier who knows what goes into that file shortens onboarding. This page sets out what the rule asks the importer to hold, how the dietary supplement rule in 21 CFR 1.511 changes the file, and where we could not confirm detail. It is a reading of the rule, not legal advice.

We read the rule on eCFR (21 CFR Part 1, Subpart L) and on FDA’s FSVP pages and small-entity compliance guide. Facility registration is covered in our US FDA and DSHEA guide, and Prior Notice in our Prior Notice guide. For the wider route into the US, see our market entry guide.

Who Holds the Program

Under 21 CFR 1.500 the FSVP importer is the US owner or consignee of the food when it is offered for import. If there is no US owner or consignee at entry, it is the US agent or representative of the foreign owner or consignee. The Indian exporter is not the FSVP importer. When a distributor or customs broker is involved, ask for written confirmation of who holds the program, and do not assume.

Two other points apply to every importer. First, under 1.503 a qualified individual must develop the program and perform each of its activities. FDA describes a qualified individual as a person with the education, training or experience needed for the activity, and says the person may be external. Second, under 1.509 the importer’s name, email address and a unique facility identifier acceptable to FDA are given electronically when entry is filed with US Customs and Border Protection. FDA’s guide says a DUNS number is acceptable, and FDA’s FSVP page says a DUNS number has been required for each food line entry since 24 July 2022.

Step One: Which Path Applies

There are two different files, and which one an importer keeps depends on how the product is regulated in the importer’s hands.

Botanical imported as food. A spice, culinary powder or tea ingredient that the importer treats as food follows the standard program in 1.502 to 1.510.
Dietary supplement or component. Importers of products subject to the dietary supplement good manufacturing practice rule (21 CFR Part 111) follow 1.511, which has three tiers.

The three tiers of 1.511 read as follows.

Tier (a): the importer sets Part 111 specifications itself. An importer that is required to establish specifications under 21 CFR 111.70(b) or (d), and that complies with 111.73 and 111.75, must have a qualified individual (1.503) and identify itself at entry (1.509). It is not required to comply with 1.502, 1.504 to 1.508 or 1.510. The same section says this does not limit its obligations under Part 111 or other laws FDA enforces, and this page does not cover the Part 111 records.

Tier (b): the importer’s customer sets the specifications. Where the customer is the party subject to those Part 111 requirements and complies with them, and the importer obtains annual written assurance of that compliance, the importer must follow 1.503, 1.509 and 1.510. It is not required to comply with 1.502 or 1.504 to 1.508. The file is therefore the annual written assurance, evidence of the qualified individual, and records kept under 1.510.

Tier (c): every other dietary supplement importer. These importers must follow 1.503, parts of 1.505, and 1.508 to 1.510, and they are not required to comply with 1.504 (hazard analysis), 1.505(a)(1)(i), 1.506 or 1.507. They have their own supplier approval and verification rules, set out below.

Which tier an importer sits in depends on its own role in the supply chain, not on the Indian supplier. Ask the importer which tier it uses and provide the documents that tier calls for. Our DSHEA guide describes FSVP in general terms, and this page is the more specific reading of the file itself.

The Standard File: Botanicals Sold as Food

For botanicals treated as food, the importer’s records follow the structure of the rule.

A written program (1.502). The importer must develop, maintain and follow an FSVP that gives adequate assurance the foreign supplier produces food under processes and procedures giving at least the same level of public health protection as the US preventive controls rules.
Evidence that a qualified individual did the work (1.503). Records of reviews must show that the review was conducted by a qualified individual.
A hazard analysis (1.504). The importer identifies and evaluates known or reasonably foreseeable biological, chemical and physical hazards. FDA’s rule lists chemical hazards such as residues, natural toxins and allergens, so for a botanical the importer decides which are reasonably foreseeable and documents why. The importer may rely on another entity’s hazard analysis if it documents its review and assessment. As we read 1.504(f), where no hazard requiring control is found, the supplier evaluation and verification steps are not required.
A supplier evaluation and approval (1.505). The evaluation considers the hazard analysis, the supplier’s procedures, processes and practices, FDA compliance information, the supplier’s food safety history, and other factors such as storage and transport. It is documented, and approval is documented. The importer must reevaluate when new information appears and at least within every three years.
Verification activity records (1.506). Before the first import the importer determines and documents which verification activity is appropriate: an onsite audit by a qualified auditor, sampling and testing, review of the supplier’s food safety records, or another appropriate activity. Where a hazard has a reasonable probability of causing serious adverse health consequences or death, the rule calls for an onsite audit before first import and at least annually, unless a written determination justifies another activity. The importer may not rely on the supplier or its employees for verification activities except sampling and testing.
Corrective action records (1.508). If a supplier does not meet the standard, or its food is adulterated or misbranded, the importer takes and documents corrective action, which can include stopping use of that supplier until the cause is resolved.

The File Under 1.511(c): Other Dietary Supplement Importers

Tier (c) importers keep a lighter file in one respect, because no hazard analysis is required. In others it is just as documented.

Approved supplier procedures. Written procedures to import only from suppliers approved on the basis of the 1.505 evaluation, with limited temporary use of unapproved suppliers where adequate verification is in place.
Written verification procedures. The importer establishes and follows them.
A documented determination of activities. Before importing, the importer documents which verification activities give adequate assurance that the supplier produces the product under processes meeting the same level of public health protection as Part 111.
Records of each activity. Onsite audits by qualified auditors that consider Part 111 requirements and review the supplier’s written food safety plan; sampling and testing, with the food identification, lot numbers, quantities tested, methods, dates and laboratory information; review of the supplier’s food safety records, with review dates and the qualified individual’s identity; or other documented activities.
A documented review of results. The importer reviews and assesses results promptly and takes action under 1.508 if the supplier is not meeting the standard.
Independence. The rule says there must be no financial conflicts of interest influencing the results of verification activities, and payment must not be related to the results.

Record Rules That Apply to Every File

Section 1.510 sets the record rules, and tiers (b) and (c) are subject to it. Records must be signed and dated when first completed and when modified. They must be kept for at least two years after the importer created or obtained them, or two years after use of the procedure is discontinued. They must be provided promptly to FDA, and offsite storage is allowed if the records can be retrieved and provided onsite within 24 hours. On FDA request, the importer must provide an English translation of records kept in another language within a reasonable time.

One provision on verification results says the importer need not retain documentation if it can obtain it and provide it to FDA as 1.510(b) requires. As we read it, a supplier-held record can count, but only if it can be produced inside the 24-hour window. That is a reason for a supplier to keep audit reports and test reports in a form that can be found quickly.

What Indian Suppliers Typically Hand Over

FDA publishes no fixed list of documents an Indian supplier must give an importer. The list below is our practice, built from what the rule asks the importer to evaluate and verify.

Facility details. The FDA food facility registration number and the facility identifier the importer will use. Registration is a separate duty, covered in our DSHEA guide.
A written description of hazard controls. The supplier’s food safety plan or equivalent, which an auditor would review on site.
Audit reports. Reports from qualified auditors with date, scope and corrective actions. Our guide to documenting an Indian GMP certificate explains how to read the certificate behind the audit.
Lot test history. Certificates of analysis from a named laboratory, with the methods and dates, over time rather than for one lot.
FDA history. Any inspection, warning letter or import alert history for the facility, or a written statement that there is none, since FDA compliance information is a factor in the evaluation.
Storage and transport conditions. These are named as a factor in the evaluation.
Identity of the real manufacturer. The evaluation looks at who significantly minimizes the hazards. For a traded lot that is the manufacturer, so a trader should name the manufacturer and pass on its documents. Our guide to manufacturer versus trader shows how to tell which you are dealing with, and our export documentation checklist covers the shipment paperwork that sits beside the FSVP file.

Quality terms agreed in the supply contract also feed the file. Our guide to quality agreements covers what to include.

Timing: When the File Must Exist

The program is not a post-shipment exercise. Supplier approval and the determination of verification activities come before the first import, and verification is performed before importing and periodically afterwards. Concerns are reevaluated when new information appears and at least once in each three-year period. A supplier asked for documents in the week a first order is being placed is being asked for what the importer needs to approve it.

What This File Is Not

The FSVP file is not the same thing as facility registration, which is the foreign facility’s duty, or Prior Notice, which is filed per shipment. It is also not the FDA food traceability rule. The Food Traceability List page we read names fresh herbs but no dried spices, turmeric, dietary supplement ingredients or botanical extracts. FDA says the traceability rule’s compliance date is 20 July 2028, and that Congress directed FDA not to enforce it earlier. An importer of dried turmeric should not assume that rule is the file it needs to build now.

What We Could Not Confirm

The exact wording of 1.504 to 1.508. The eCFR API is blocked to automated readers by robots.txt. We read these sections through summaries of the eCFR page. Section 1.511 was consistent across three readings and in FDA’s small-entity guide.
Section 1.512. The provisions for very small importers and certain small foreign suppliers were not read in full and are not covered here.
Which tier an importer uses. That depends on the importer’s own role and Part 111 status.
Supplier certificates of analysis. The rule bars reliance on the supplier for verification activities other than sampling and testing. FDA’s small-entity guide does not say how much weight a supplier’s own certificate carries, so that is the importer’s documented judgment.
A fixed supplier document list. None found, so the list above is our practice, not FDA’s.
Legal status. This is a reading of the rule, and an importer should confirm its position with its own regulatory adviser.

Working With Ayris Global

If you are a US importer or brand owner building an FSVP file for an Indian botanical, set out the ingredient, form and intended use on our for buyers page, or write through the contact page. If you are an Indian producer preparing documents for a US importer, start on the for suppliers page.

Ready to specify your order? Visit the for buyers page or contact Ayris Global.

Frequently Asked Questions

Does FSVP apply to the Indian supplier directly?

No. FSVP is a duty of the US importer, defined as the US owner or consignee at entry or, if there is none, the US agent or representative of the foreign owner. The Indian supplier supplies documents that the importer needs for its own file.

Does a US importer of dietary supplement ingredients need a hazard analysis?

Under 21 CFR 1.511, no tier requires one. Importers that set Part 111 specifications, importers whose customer does and gives annual written assurance, and other dietary supplement importers each follow different parts of the rule. Botanicals imported as ordinary food follow the standard program, which does include a hazard analysis.

How long must FSVP records be kept?

At least two years after the importer created or obtained them, or two years after use of the procedure ends. Records must be signed and dated, available to FDA promptly, and retrievable onsite within 24 hours if stored offsite. FDA can ask for an English translation of records kept in another language.

Can an importer rely on the supplier’s own certificate of analysis?

The rule bars reliance on the supplier or its employees for verification activities except sampling and testing. How much weight a supplier’s own certificate carries is the importer’s documented judgment, and FDA’s small-entity guide does not address it. A certificate from a named laboratory with methods and dates is easier to defend.

Who is the FSVP importer when a distributor clears the goods?

The FSVP importer is the US owner or consignee at the time of entry. A distributor that is the owner or consignee may hold the program, but the rule looks at the entry, not at the commercial arrangement. Ask for written confirmation of who holds it before the first shipment.