The Hidden Reasons It’s Hard to Find a Quality Contract Manufacturer
We dive into the big reasons why finding reliable, high quality supp
“Who do you recommend for manufacturing?” is the most common question from new supplement brands. The short answer—“it depends”—is unsatisfying but honest. The long answer explains why great manufacturers are rare, howweaker shops look credible online, and what a brand should demand before sending deposits. This post breaks down the landscape, decodes a real quote (anonymized), and closes with a pragmatic path forward for brands that want staying power—not one-and-done runs.
Why finding a solid partner is so hard
1) A flood of startups… and copycats
Lower barriers (capsule presses, mixers, turnkey label vendors) created many “manufacturers” who treat GMP like a costume. Some simply don’t know what they don’t know; others copy what they see competitors doing—often repeating the same compliance gaps.
2) “One-and-done” business models
Certain shops optimize for quick deposits and minimal deliverables. Marketing pages tout “GMP” and “FDA registered,” but internal processes, documentation, and test plans don’t match the promise. The goal is the first PO, not a multi-run relationship.
3) Contracts that push liability onto the brand
It’s common to see quotes and terms that:
Reference 21 CFR 111 responsibilities (to you) without stating the factory’s specific obligations.
Limit included testing to basic micro (TAMC/TYMC/pathogens)—omitting identity, potency/assay, heavy metals, pesticides, residual solvents, and allergen controls unless you pay extra.
Add indemnity language that effectively says: “If you test and don’t like it, that’s on you.”
Result: brands believe “testing is handled,” only to learn after a retailer screen or third-party check that core specs were never run.
4) Brokers posing as manufacturers
Plenty of slick “facilities” are actually middlemen. Some add value; many don’t. Red flags:
Separate LLC “sales arm,” vague site photos, no real address or virtual tours.
Dodging technical questions (“We’ll check with production”) because there is no production.
Extra delay and cost when issues arise (you → broker → actual plant).
5) Google rewards SEO, not quality
The shops ranking on page one are great at lead capture, not necessarily at GMP. The best facilities get work through networks, referrals, audits, and trade shows—not search ads. That doesn’t mean everyone online is bad; it means visibility ≠ capability.
6) Good manufacturers screen you
Strong plants want brands that understand MOQs, lead times, realistic COGS, and compliance. If outreach feels unprepared (no brief, no projections, throwaway email domains), expect slow replies—or a pass. They make money on repeatable, scalable business.
What a weak quote looks like (and why it matters)
An anonymized real-world example (heavily redacted) looked polished: unit counts, pricing, capsule/bottle choices, “GMP” badges. Hidden in the fine print:
Testing included: only microbiological limits.
Potency/assay: not included, not mentioned.
Heavy metals/allergens: silent.
Liability: brand acknowledges 21 CFR 111 duties; factory disclaims responsibility for any additional testing the brand “chooses to perform.”
To a newcomer, it reads “comprehensive.” To an experienced reviewer, it screams risk. If a retailer (or competitor’s lab) checks potency/metals later and your lots fail, you own the problem—and the recall math.
The minimums a serious brand should require
Use this as your baseline (categories may vary by product):
Finished product testing (per lot):
Identity of actives (appropriate methods per ingredient class).
Assay/Potency vs. label claim for all actives (with validated methods).
Microbiology: TAMC/TYMC, pathogens as applicable.
Heavy metals: As, Cd, Pb, Hg (limits aligned to internal policy/retailer standards).
Allergens as applicable; gluten if claiming gluten-free.
Other contaminants as relevant (pesticides/residual solvents for botanicals/extracts; oxidation/rancidity for high-fat matrices).
Raw materials:
Supplier qualification, CoA verification, ID on receipt (100% or validated skip-lot), risk-based contaminant controls.
Stability plan:
A path to substantiate shelf life (real-time preferred; accelerated to support interim dating). Build in assay/micro/organoleptic checkpoints.
Documentation you should see or reference:
Master Manufacturing Record (MMR) and Batch Production Record (BPR) templates.
Specifications (raw, in-process, finished).
Deviation/CAPA process.
Change control policy.
Complaint/recall procedures.
Contract language to look for (or add)
Included testing matrix with methods, limits, and who pays.
Retain samples (quantity and duration).
Access rights for audits (remote and on-site), document reviews, and CAPA follow-up.
Non-conformance remedies: remake, credit, or refund triggers tied to failing agreed specs.
Change control: manufacturer must notify and obtain approval for material changes (suppliers, methods, equipment) affecting your product.
Confidentiality that explicitly protects your formulas and trade secrets.
If these items are “not our standard,” that’s data.
A practical vetting workflow (fast but real)
Pre-brief (you): Nail your product brief—form factor, target claims (compliant), target COGS/MSRP, projected volumes, testing expectations, shelf-life target, artwork timing, and launch window.
Shortlist (3–5 plants): Network/refs > trade associations > shows > selective web outreach.
Technical screen (30–45 min each): Quality leadership present, not just sales. Review testing panel, method suitability, stability approach, and retailer program familiarity (e.g., CVS/Costco specs).
Paper audit: Request sample MMR/BPR redacted, spec sheets, SOP table of contents, certification scope (NSF/UL/USP where relevant).
Quote apples-to-apples: All include identical BOM, batch size, packaging, and the same testing matrix.
Visit or virtual tour: Layout, hygiene zoning, weigh/dispense controls, segregation, label control, quarantine/hold-release.
Pilot or engineering run: If feasible, before committing to full MOQs.
Lock contracts + QC plan: Bake the testing matrix and stability plan into the SOW; align on retain samples and release criteria.
Red flags that save you months (and money)
“FDA approved facility” (facilities aren’t “approved”).
Only micro testing included; potency/metals are “extra if you want them.”
Unwilling to share even redacted QA documents or to host quality on a call.
Broker evasiveness: can’t confirm physical address or allow a walkthrough.
Pressure for big deposits before specs/test plans are set.
Resistance to change control or non-conformance remedies in contracts.
“We don’t do stability” for shelf-life products that clearly need it.
So… who should you use?
There is no universal “best.” A plant that’s perfect for one brand (format, actives, lead times, MOQs, budget, retailer targets) can be a poor fit for another. Leadership turnover, method shifts, and supplier changes can also move a “great” partner into “not for us” territory within months.
What does work: a repeatable selection process and curated relationships. For brands that meet certain readiness thresholds (funding, MOQs, timelines, expectations), we can fast-track introductions to vetted facilities where we already understand the QA programs, testing norms, and change-control culture—while still running a proper fit assessment for your specific formula. It’s not right for everyone, and it’s not the cheapest route—but it’s built for brands that want to scale without quality roulette.lements manufacturers is so difficult and why google isn’t the best source of information. And, of course, how to find a great supplement contract manufacturer.
FAQ: Contract Manufacturers & Vetting
Q1) What’s the difference between “FDA registered” and “FDA approved”?
Facilities aren’t “approved.” Many must register with FDA and are subject to inspection. Approval applies to certain products (e.g., drugs), not supplement plants. Treat “FDA approved facility” as a red flag.
Q2) Which GMP certifications actually matter?
NSF/ANSI 455-2 (or 173/214 legacy), UL GMP, and USP for specific processes/ingredients are meaningful. Ask for an active certificate, scope, and last audit date—not just a logo on a website.
Q3) What testing should be included in my quote by default?
At minimum per lot: identity of actives, assay/potency vs label claim, micro (TAMC/TYMC + pathogens as applicable), heavy metals (As, Cd, Pb, Hg), plus any allergen/gluten testing tied to claims. Add pesticides/solvents for botanicals, oxidation for high-fat matrices, where applicable.
Q4) Who pays for testing—me or the manufacturer?
Ultimately you do (baked into COGS or as line items). The key is to specify the matrix and methods in the contract so nothing “falls off” later.
Q5) Do I need real-time stability, or is accelerated enough?
Use accelerated to support initial dating, but plan real-time to substantiate shelf life. Retailers may ask for your stability protocol and interim data before onboarding.
Q6) How do I avoid brokers posing as manufacturers?
Request a site address, quality contact, virtual tour, and redacted MMR/BPR samples. Ask who signs release. If answers get routed elsewhere and no tour is possible, you’re likely dealing with a broker.
Next steps
1) Book a 1:1 Regulatory & Manufacturing Consultation
Pressure-test your brief, refine claims, set the testing/stability protocols, and leave with a shortlist and outreach script.
→ Schedule your two-hour consult
2) Get the Supplement Startup Essentials Training (SSET)
Learn how to vet manufacturers, understand testing,, and build labels/claims that meet FDA requirements.
→ Enroll in SSET (bundle available with 1:1 consult)
3) Established brands: manufacturer transition or QA uplift
If you’re preparing for retail expansion or diligence, we audit current partners, upgrade QA docs/testing plans, and manage smooth plant transitions when needed.
→ Contact us for an established-brand assessment
About Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and functional food brands launch, scale, and get investor-ready without tripping over FDA/FTC pitfalls. Services include formulation and claim strategy, label/website reviews, QA/GMP system build-outs, manufacturer vetting, stability/testing plans, and retailer/diligence packets. The goal: a brand that wins consumer trust today and passes investor diligence tomorrow.