Should You Work With Nutracaps? A Compliance-First Vetting Walkthrough (Not a “review”)

Aug 8

Written By 101 Mentor

Summary (Key takeaways)

I haven’t worked with Nutricaps. This is not a review—it’s a due-diligence walk-through you can copy for any supplement contract manufacturer.
Website gaps to verify: vague on dosage forms, “Made in USA” nuance, “FDA registered” (baseline), and unspecified GMP certifier—ask for proof.
Public record signals (as reported): an FDA warning letter (2020) citing change-control and testing issues, and a recall (2021) for undeclared allergens. Use these as prompts for deeper questions and audits.
Would I contact them? Sure—no harm in an introductory call. Would I choose them now? I’d prioritize other options unless they can show clear, verifiable improvements in quality and compliance.
Use the 10-point diligence checklist below to protect your brand—whoever you choose.

Who they serve & how: stock vs. custom formulas, label/design support, “low minimums,” “fast lead times.” Good—but promises must be verifiable.
Dosage forms: capsules, tablets, powders, gummies, softgels, liquids? If the site doesn’t say, confirm.
Certifications, clearly named: GMP (by which body?), USDA Organic scope (handler vs. processor), Halal/Kosher if relevant. “FDA registered” is required of everyone; it’s not special.
Claims nuance: “Made in USA” has FTC rules; facilities can be US-based while ingredients are globally sourced. Don’t over-claim.

From the information you referenced:

FDA warning letter (2020): cited change-control lapses (ingredient quantities altered without QA approval), inadequate heavy-metal testing strategy (over-reliance on supplier CoAs without full qualification), and use of DMHA (an impermissible additive).
Recall (2021): undeclared allergens (wheat/dairy/soy/coconut) found during follow-up inspection, affecting multiple brands.

Treat these as conversation starters, not final verdicts. Many firms level-up after a warning letter; others don’t. Your job is to verify.

Named GMP: Ask for the current GMP certificate, the issuing body (e.g., NSF/UL/NPA/SGS), scope, and last audit date + closeout of findings.
Full spec package: Finished-product specification covering identity, potency, purity (micro & heavy metals), and composition—plus allergen limits if relevant (e.g., gluten-free).
Testing plan: Written release testing for incoming (identity + risk-based safety), in-process, and finished product. Clarify when they rely on supplier CoAs vs. confirmatory tests.
Change control: Show me their SOP that prevents unapproved formula/label changes, and examples of approved change records.
Allergen control: Line scheduling, cleaning validation, and verification (e.g., ELISA swabs) to back any “free-from” claims.
Ingredient screen: Formal banned/novel list (e.g., DMHA) + a pre-formulation legal review (NDI/GRAS/food-additive status).
Recall readiness: Recall SOP, mock-recall times, and traceability reports (lot-up/lot-down within hours).
Stability plan: If you want a shelf life, what’s the protocol (timepoints, conditions, endpoints)?
Label support: Who signs off on Supplement Facts formatting, claims substantiation, and (if needed) structure/function notifications to FDA?
Tour/Audit: Virtual or on-site walkthrough; look for gowning, material flows, pest control, sanitation logs, environmental monitoring, and training records.

Pro tip: Ask for a redacted example CoA and BPR (batch record). If the formats are thin, your release decisions will be thin too.

Initial outreach: Yes—get pricing, MOQs, forms, documentation samples, and talk through how they addressed the 2020/2021 issues.
Selection today: With only what’s publicly noted and what’s missing on the site, I’d likely keep vetting other manufacturers in parallel. If Nutricaps demonstrates robust corrective actions (and you confirm via audit), they could move back into consideration.

Draft your label & claims now (even in a doc) to surface testing and legal needs early (Amazon/retail-friendly).
Send the 10-point doc request to 2–3 shortlisted CMs; compare depth, not just price/lead time.
Schedule a tour/audit and bring a compliance lens (or a partner who has one).
Lock a lab for independent spot-checks (identity/potency + micro/metals) and clarify methods upfront.
Set your verification plan (reserve samples, skip-lot rules, when to escalate to full panels).

Signature 1-on-1 Consultations
Bring your shortlist and draft label. I’ll act as your advisor/compliance partner, pressure-test claims and specs, build your manufacturer vetting checklist, and outline an audit plan you can actually run.
SSET: Supplement Startup Essentials Training
A practical program for founders to understand what regulations apply, build a crisp market brief, learn how to find and vet co-mans, and align claims, testing, and channel requirements (Amazon/retail) before you spend on inventory.

101 Mentor