Eniva USA, Inc.: due-diligence report
Public-record summary and buyer worksheet. Records can be incomplete; a listing is not product approval, an audit result or a guarantee of suitability. This report updates as source records change. Print a dated copy to retain the version you reviewed.
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Profile last verified: Nov 1, 2026. Report printed / reviewed on: ____________________
Certifications and licences
NSF/ANSI 455-2 GMP for Dietary Supplements
Issuer: NSF. Registry status: active. Checked: Nov 1, 2026.
Reference: Not recorded. Expiry: Not recorded.
Scope: Not recorded here; confirm with the registry and manufacturer.
Registry source: https://info.nsf.org/Certified/455GMP/Listings.asp?Facilities
Eniva USA, Inc., 2700 Campus Drive, Plymouth, MN, 55441, US — manufacturing; source: NSF/ANSI 455-2; checked Nov 1, 2026.
FDA inspection history
Dataset date: Oct 22, 2026. Facility records are matched by company and location; confirm that the site is the one in your quote. FDA inspection source.
Jan 13, 2025 — OAI: Official action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 1258323.
Colors and Cosmetics Technology, Food Composition, Standards, Labeling and Econ, Foodborne Biological Hazards
21 CFR 111.27(b): Instruments - calibration
21 CFR 111.70(b): Specifications - components
21 CFR 111.70(e): Specifications - finished dietary supplement
21 CFR 111.75(a)(1)(i): Component - verify identity, dietary ingredient
21 CFR 111.113(a)(1): Quality control production, process control; material review, disposition
21 CFR 111.255(c): Batch record - follow master
21 CFR 111.260: Batch record - required information
21 CFR 111.320(a): Examination, testing; appropriate
21 CFR 111.320(b): Examination, testing; scientifically valid
21 CFR 111.365(a): Conditions, controls -protect; microorganisms, contamination
21 CFR 114.83: Scheduled process establishment
Aug 31, 2022 — VAI: Voluntary action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 1178616.
Food Composition, Standards, Labeling and Econ
21 CFR 111.75(a)(2)(ii)(D): Re-confirm certificate of analysis
Aug 6, 2018 — NAI: No action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 1065627.
Food Composition, Standards, Labeling and Econ
Aug 18, 2017 — VAI: Voluntary action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 1023031.
Food Composition, Standards, Labeling and Econ
21 CFR 111.10(b)(6): Hair restraints
21 CFR 111.10(b)(8): Food, gum, beverages, tobacco
21 CFR 111.15(i): Hand-washing facilities
21 CFR 111.25: Equipment - procedures
21 CFR 111.27(a): Equipment - design - suitable
21 CFR 111.27(d)(4): Contact surfaces - not in direct contact - cleaning
21 CFR 111.113(a)(1): Quality control production, process control; material review, disposition
21 CFR 111.113(a)(2): Quality control master manufacturing record; material review, disposition
21 CFR 111.210(g): Packaging description, representative label
21 CFR 111.260(l)(1)(i): Batch record - quality control review; monitoring
21 CFR 111.560(b): Quality control, review, approve; investigate, follow-up
Jul 16, 2015 — VAI: Voluntary action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 933553.
Food Composition, Standards, Labeling and Econ
Oct 2, 2012 — VAI: Voluntary action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 801483.
Colors and Cosmetics Technology, Food Composition, Standards, Labeling and Econ
Feb 3, 2011 — NAI: No action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 708219.
Food Composition, Standards, Labeling and Econ
Sep 11, 2009 — OAI: Official action indicated
Eniva USA, Inc., Plymouth, Minnesota, United States. FEI: 3003167539; inspection: 611611.
Food Composition, Standards, Labeling and Econ
FDA recalls
Dataset date: Oct 27, 2026. Recall matches use company names and may concern a different product or facility.
No matched recall events in the imported dataset. This is not proof of a recall-free history.
Company website claims — not registry verified
Last website check: Oct 16, 2026.
“Eniva® Omega-3 EPA/DHA/DPA Efacor® Essential Fatty Acids Fish Oil provides premium potency and purity in a specialized supplement containing high-dose EPA and DHA.”
Last seen Oct 16, 2026. https://eniva.com/premium-ultrapure-fish-oil-omega-3-with-epa-dha-dpa-high-potency-efacor/
“Top dietary supplement offerings include whole food based liquid multivitamins and multiminerals, antioxidants , omega 3 fish oil, Vitamin C, Vitamin D, protein, zinc, B-complex,”
Last seen Oct 16, 2026. https://eniva.com/
“Doctor Formulated. Gluten Free, Soy Free. "Friend of the Sea" Certified for sustainable & responsible sourcing.”
Last seen Oct 16, 2026. https://eniva.com/premium-ultrapure-fish-oil-omega-3-with-epa-dha-dpa-high-potency-efacor/
Evidence to request from the manufacturer
Public records cannot answer these questions. Mark each item after reviewing the evidence. Blank means not assessed, not a failed audit. Notes entered here are not saved or included in a shared URL.
Request role-specific training records and the named quality contact.
21 CFR 111.12Request a site walkthrough, sanitation controls and equipment maintenance records (also §111.25).
21 CFR 111.20Request written identity, purity, strength, composition and contaminant specifications for your product.
21 CFR 111.70Ask how each dietary ingredient is identified and how suppliers and certificates of analysis are qualified.
21 CFR 111.75Request quality control procedures, release authority and handling of deviations and rejected batches.
21 CFR 111.105Request the approved product-specific master manufacturing record and change-control process.
21 CFR 111.205Review a completed batch record with traceability to components, processing and release.
21 CFR 111.255Request scientifically valid test methods, sampling plans and laboratory controls for your specifications.
21 CFR 111.315Request procedures that prevent label mix-ups and control packaging and label reconciliation.
21 CFR 111.403Ask how storage conditions protect identity, purity, strength and composition during holding and distribution.
21 CFR 111.453Request complaint review and investigation procedures; discuss returned-product controls under §111.503.
21 CFR 111.553Confirm retention and access to records supporting your batches.
21 CFR 111.605