GMP Certified Supplement ManufacturerFDA-Registered · 21 CFR Part 111 Compliant
Every batch we produce meets the same cGMP standard the FDA enforces on US facilities. FDA-registered for US export, ISO 9001 & 22000 certified, HACCP compliant, and independently tested by third-party accredited laboratories. Your brand is only as safe as your manufacturer — we take that seriously.
Certifications on file
Why cGMP Certification Matters — And What Happens When It's Missing
The dietary supplement industry sells roughly $65 billion in product every year, and the overwhelming majority of it moves through private-label channels. That means the brand on the label is almost never the company that actually made what's in the bottle. Which is exactly why the FDA, Amazon, major retailers, and state attorneys general all look at the manufacturer — not the brand — when something goes wrong. If you're launching a supplement line, your manufacturer's quality posture is your quality posture. Full stop.
A non-cGMP manufacturer is not a hypothetical risk. FDA publishes warning letters weekly for facilities that fail 21 CFR Part 111 — and when those letters hit, every brand sourcing from that facility inherits the problem. Amazon has escalated enforcement: a third-party testing failure or an FDA warning letter now results in immediate ASIN suspension, often with inventory destruction. Brand recovery from an Amazon supplement suspension takes months, costs five figures in legal and lab work, and frequently ends in permanent de-listing. Major retailers (Whole Foods, Target, CVS, Walmart) require cGMP certification and third-party COAs as a precondition to onboarding — no cGMP, no shelf.
Then there's legal exposure. In the United States, if your product fails testing and causes harm, the liability travels through your label to you first. Your manufacturer's insurance is the backstop, but only if the manufacturing contract and the quality documentation hold up to discovery. Prop 65 suits over undeclared lead and cadmium have become a cottage industry in California, with thousands of supplement brands targeted annually. A clean COA from a cGMP facility is your first and best defense.
The economics are simple: certification costs us, not you. You don't pay extra for a cGMP facility versus a non-certified one — you pay extra later if you chose the wrong one. Our seven certifications exist because every serious retail buyer and every serious marketplace requires them, and because we'd rather build products that can be sold for the next ten years than products that look cheap on a spreadsheet for six months.
Our 7 Certifications
Every certification below is audited by an independent third-party body. Certificates and current audit reports are available on request under NDA.
FDA Registered
- What it covers
- Registration as a foreign food facility under the US Bioterrorism Act and 21 CFR Part 111 compliance for dietary supplement export to the United States.
- What it proves
- The facility is legally cleared to manufacture dietary supplements destined for the US market and is subject to FDA inspection authority.
- Audited by
- US Food & Drug Administration (registration renewed biennially)
cGMP — current Good Manufacturing Practice
- What it covers
- Personnel training, sanitation, equipment qualification, raw material identity testing, in-process controls, finished product release, and record retention.
- What it proves
- Every batch is produced under documented, repeatable procedures that ensure identity, purity, strength, and composition match the label.
- Audited by
- Independent GMP certification body, audited annually
ISO 9001:2015
- What it covers
- Quality Management System covering leadership, planning, support, operations, performance evaluation, and continuous improvement across the entire business.
- What it proves
- Quality is not an add-on — it is built into every process from sales inquiry to shipment.
- Audited by
- Accredited ISO certification body, annual surveillance audits
ISO 22000
- What it covers
- Food Safety Management System integrating HACCP principles with prerequisite programs for ingestible product manufacturing.
- What it proves
- Food-safety hazards are systematically identified, controlled, and verified throughout the supply chain — not just at final inspection.
- Audited by
- Accredited ISO certification body, annual surveillance audits
HACCP
- What it covers
- Hazard Analysis and Critical Control Points — a preventive approach that identifies biological, chemical, and physical hazards at each step of production.
- What it proves
- Critical control points are monitored continuously and corrective actions are documented whenever limits are exceeded.
- Audited by
- Independent food-safety auditor
Halal Certification
- What it covers
- Verification that ingredients, processing aids, equipment cleaning, and storage comply with Islamic dietary law.
- What it proves
- Products are suitable for the 1.9 billion-consumer global Halal market, including Indonesia, Malaysia, and the GCC.
- Audited by
- Accredited Halal certification body
Kosher Certification (OU)
- What it covers
- Orthodox Union supervision of ingredients, equipment, and production runs to ensure compliance with Jewish dietary law.
- What it proves
- Products carry the OU mark — the most widely recognized Kosher symbol in global retail.
- Audited by
- Orthodox Union (OU) rabbinical supervision
21 CFR Part 111: What It Actually Requires
21 CFR Part 111 is the United States' enforceable rulebook for dietary supplement manufacturing, written by the FDA and binding on every facility that manufactures, packs, labels, or holds dietary supplements sold into the US market. It runs to more than 100 pages of regulation and is organized around six pillars. Every cGMP-certified facility must demonstrate compliance with all six — not a selection.
What follows is a plain-language tour. We comply with each section in full and can supply auditor documentation for any of them on request.
Subpart B — Personnel
Every employee who touches a dietary supplement must be trained, qualified, and documented. Training records are retained. Employees with illness or contamination risk are kept off production. Qualifications are re-verified periodically, not assumed forever.
Subpart C — Physical Plant & Grounds
The building must be designed to prevent cross-contamination, pests, and microbial growth. Separate rooms for raw materials, production, packaging, and quarantine. Documented cleaning and sanitation schedules. Water quality testing. Integrated pest management.
Subpart D — Equipment & Utensils
Every piece of equipment that contacts product must be cleanable, qualified, and calibrated. Calibration records for scales, thermometers, and analytical instruments are retained. Equipment is identified and logbooks track every production run.
Subpart E — Production & Process Controls
A written master manufacturing record defines how each product is made, step by step. Batch records capture what actually happened during production. In-process controls — weight, blend time, temperature, moisture — are monitored and documented in real time.
Subpart F — Quality Control
A Quality Unit independent of production has the authority to reject raw materials, in-process material, and finished products. Identity testing on raw materials is mandatory. Finished product testing confirms specifications. Nothing ships without Quality Unit release.
Subpart P — Records & Documentation
Every record — training, cleaning, calibration, receiving, production, testing, release, complaint — must be retained for at least one year past shelf life or two years past the date of distribution, whichever is longer. If it wasn't written down, regulators treat it as if it didn't happen.
Quality Testing Protocol
Six test categories, run on every batch, using validated analytical methods. Both in-house and at an independent ISO 17025 accredited laboratory.
Identity Testing
FTIR / HPLCEvery incoming raw material is identity-verified against a reference standard. Fourier-transform infrared spectroscopy (FTIR) and high-performance liquid chromatography (HPLC) catch mislabeled, substituted, or adulterated ingredients before they ever enter a blend.
Potency Testing
HPLC / UPLCQuantitative assays confirm that the actual milligram content of each active ingredient matches the label claim, within the tight tolerances required by 21 CFR Part 111 (typically ±10% of declared value).
Purity Testing
GC-MS / LC-MSScreens for pesticide residues, residual solvents, adulterants, and undeclared pharmaceutical compounds. Essential for botanical ingredients where adulteration with synthetic drugs is a documented industry risk.
Microbial Testing
USP <61> / <62>Total aerobic microbial count, yeast and mold, plus specific pathogens: E. coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa. Run on every finished batch, not just on raw materials.
Heavy Metals
ICP-MSInductively coupled plasma mass spectrometry for lead, arsenic, cadmium, and mercury — the four heavy metals regulated under Prop 65 in California and increasingly scrutinized by state AGs and retail buyers.
Stability Testing
ICH Q1A guidelinesReal-time and accelerated stability studies confirm that every active ingredient retains at least 100% of label claim throughout the declared shelf life — so a product that claims 1,000 mg on day 1 still delivers 1,000 mg on day 730.
What's in a Certificate of Analysis (COA)
A Certificate of Analysis is the document that turns "we made this" into "we can prove it." It is the single most important compliance artifact in the supplement industry, demanded by retailers, marketplaces, regulators, and plaintiff's attorneys. Every batch we release ships with a full COA covering eight required elements:
- Product name, SKU, and full label identification
- Lot / batch number and manufacturing date
- Expiration date and declared shelf life
- Identity test results for every active ingredient
- Quantitative potency results (label claim vs. actual measured)
- Microbial results: total plate count, yeast/mold, E. coli, Salmonella
- Heavy metals: lead, arsenic, cadmium, mercury (in ppm)
- Quality Unit signature and batch release date
Retained for a minimum of one year past shelf life, per 21 CFR Part 111 Subpart P.
Example Batch COA
Lot #BYB-2026-0412-A
| Test | Spec | Result | Status |
|---|---|---|---|
| Vitamin C (Ascorbic Acid) | 1,000 mg / serving | 1,042 mg | PASS |
| Zinc (Picolinate) | 15 mg / serving | 15.3 mg | PASS |
| Lead (Pb) | < 0.5 ppm | < 0.05 ppm | PASS |
| Arsenic (As) | < 1.0 ppm | < 0.10 ppm | PASS |
| Total Plate Count | < 1,000 cfu/g | < 10 cfu/g | PASS |
| E. coli | Absent / 10 g | Absent | PASS |
| Salmonella | Absent / 25 g | Absent | PASS |
Third-Party Lab Testing: Why Internal Testing Alone Isn't Enough
Internal quality control is necessary but insufficient. The same entity that makes a product cannot be the only one certifying it — that's a textbook conflict of interest, and it's exactly what FDA warning letters cite when a facility's internal COAs don't match reality. A credible COA has to be independently verified.
We run every finished batch through ISO 17025 accredited third-party laboratories — including Eurofins and regional NSF-affiliated partners — for potency, heavy metals, purity, and microbial testing. ISO 17025 is the international standard for testing and calibration laboratory competence; it's the benchmark that separates a real analytical lab from a pay-for-results certificate mill. Our internal results and the third-party results must agree within validated method tolerance before a batch is released.
Clients who want extra assurance can nominate their own lab — common choices include Eurofins, Alkemist Labs, Covance, and ChromaDex — at their own cost. We ship samples directly and the results go to both parties. This is how NSF Certified for Sport programs work, and it's available as a standard option on our platform.
The reason single-source testing fails is not malice, it's math. An analytical method will drift over time. Reference standards degrade. Operators make procedural errors. A second independent lab catches what the first one missed. For a brand that intends to sell on Amazon or into retail for the next decade, this redundancy is the difference between a quiet 2026 and a recall in 2027.
Our Quality Assurance Process
Incoming Raw Materials
Every shipment is quarantined on arrival. Quality Control draws samples, performs identity testing (FTIR/HPLC), verifies the supplier Certificate of Analysis, and issues a Release or Reject decision. No raw material enters production without written QC release.
In-Process Checks
At every production stage — weighing, blending, encapsulation or molding, coating, packaging — documented in-process checks verify blend uniformity, fill weight, moisture, and visual defects. Any out-of-spec reading halts the line and triggers a deviation report.
Pre-Packaging QA
Before product moves to labeling and packaging, the Quality Unit reviews the full batch record, reconciles yields, and signs off that the in-process data is complete. Incomplete records block release.
Third-Party Verification
Samples from the finished batch are shipped to an independent ISO 17025 accredited laboratory for potency, purity, heavy metals, and microbial verification. Internal and third-party results must match within method tolerance before release.
Final Release
Only the Quality Unit can authorize a batch for shipment. Release requires: complete batch record, passing internal QC, passing third-party results, approved Certificate of Analysis, and approved label artwork. No exceptions.
Stability Monitoring
Retained samples from every batch are placed in controlled stability chambers (25°C/60% RH long-term and 40°C/75% RH accelerated) and tested at defined pull points across the declared shelf life. This is how a shelf-life claim is actually earned — not just printed.
Regulatory Compliance Beyond the USA
FDA compliance gets the spotlight, but the supplement market is global — and every jurisdiction has its own rules. A real compliance partner ships your brand into any market you sell in, with the right documentation in the right format.
European Union
Food Supplements Directive (2002/46/EC) compliance, EFSA-approved ingredient list verification, EU-compliant labeling in all required languages, and Notified Food Business Operator documentation for import into any EU member state.
Halal Export Markets
Halal certification recognized across Indonesia (BPJPH/MUI), Malaysia (JAKIM), the GCC, and North Africa. Covers ingredient sourcing, processing aids, equipment cleaning, and storage segregation.
Japan & South Korea
Foods with Function Claims (FFC) preparation for Japan's Consumer Affairs Agency, and Health Functional Food (HFF) documentation for Korea's MFDS. Includes ingredient whitelists and labeling format translation.
United Kingdom, Canada & Australia
Post-Brexit UK food supplement compliance, Health Canada Natural Health Product (NHP) and NNHPD requirements, and Australian Therapeutic Goods Administration (TGA) listing support.
Explore More
Private Label Supplements
500+ stock formulations across gummies, capsules, powders, and drops — ready to ship under your brand from our cGMP facility.
Learn moreCustom Supplement Manufacturing
Proprietary formulations with full R&D support, produced under the same cGMP and third-party testing protocols described on this page.
Learn moreFrequently Asked Questions
The compliance questions we hear most often from buyers in due diligence.
What does cGMP certified mean for supplement manufacturing?
cGMP stands for current Good Manufacturing Practice. A cGMP-certified supplement manufacturer has been independently audited against a living set of quality standards that govern personnel training, facility design, equipment calibration, raw material identity testing, in-process controls, finished product testing, and record keeping. In the United States, cGMP for dietary supplements is codified under 21 CFR Part 111 and enforced by the FDA. A cGMP certification means every production batch is made, tested, and documented the same way, every time — so what is on the label is actually in the bottle.
What is 21 CFR Part 111?
21 CFR Part 111 is the section of the US Code of Federal Regulations that sets the mandatory Good Manufacturing Practice requirements for dietary supplements. It covers six major areas: personnel qualifications and training, physical plant and sanitation, equipment and utensils, production and process controls, quality control operations, and records and documentation. Every dietary supplement sold into the US market — whether manufactured domestically or imported — must be produced in a facility that complies with 21 CFR Part 111. FDA inspectors audit facilities against this standard and issue warning letters or import alerts for violations.
Is your facility FDA registered?
Yes. Our facility is FDA-registered as a foreign food facility under the Bioterrorism Act and produces dietary supplements in full compliance with 21 CFR Part 111. FDA registration is required for any facility that manufactures, processes, packs, or holds dietary supplements for import into the United States — it is separate from, and independent of, physical location. Our registration is current, renewed biennially, and we maintain a US Agent of record as required by FDA.
What certifications does your facility hold?
Seven independent certifications: FDA Registration, cGMP (21 CFR Part 111), ISO 9001:2015, ISO 22000, HACCP, Halal, and OU Kosher. Each is audited annually by an independent third-party body. Certificates are available on request under NDA.
How do you ensure product quality and potency?
A six-stage protocol: raw material identity testing, in-process checks at every production stage, pre-packaging QA review, third-party verification, Quality Unit final release, and stability monitoring across the full declared shelf life. Every finished batch ships with a Certificate of Analysis.
What is a Certificate of Analysis (COA)?
A formal quality document issued for every manufactured batch that proves the product meets its label claims and safety specifications. Contains identity, potency, microbial, heavy metal, and physical test results, lot and expiry dates, and Quality Unit sign-off. COAs are retained for a minimum of one year past shelf life.
Do you do third-party testing?
Yes. In addition to our in-house quality control lab, every production batch is also verified by an independent ISO 17025 accredited contract laboratory. Internal testing alone creates a conflict of interest. Clients can also nominate their own preferred lab at their cost.
What happens if a batch fails quality testing?
Any batch that fails a critical specification is immediately quarantined and cannot be released. Under 21 CFR Part 111, a failed batch triggers a formal Out-of-Specification investigation. Depending on root cause, the batch is reworked (where regulations allow), downgraded to non-dietary use, or destroyed. Failed batches are never shipped to clients.
Choose a Quality Partner You Can Defend in Any Audit
cGMP. FDA-registered for US export. 21 CFR Part 111 compliant. ISO 9001 & 22000. HACCP. Every batch third-party tested. Every batch shipped with a full Certificate of Analysis. No shortcuts, no exceptions.