AQL 0
Zero tolerance
Anything that makes a product unsafe or non-compliant — contamination, wrong ingredient, failed identity testing. One critical defect fails the lot.
Independent quality assurance
Know what’s shipping before it leaves the factory.
On-site product inspections, AQL sampling, and supplier audits for dietary supplement, food, personal care, and cosmetic brands — from a quality director who’s done it at scale.
$724K+Supplier compensation negotiated across 2024–2025
−50%Customer returns after rebuilding the returns program
10+Years of quality leadership across four regulated categories
5Markets under direct regulatory responsibility
The standard
What a quality product actually looks like.
Every inspection we run follows the same discipline the industry’s best manufacturers use. Here’s the framework — no mystique, just method.
AQL 2.5
Functional failures
Defects that break the product’s purpose or specs — underfilled counts, broken seals, mislabeled strength. Sampled against a 2.5% limit.
AQL 4.0
Cosmetic imperfections
Flaws that don’t affect safety or function — scuffed labels, minor print shifts. Tracked, trended, and held to a 4.0% limit.
Every inspection covers five checkpoints
Quantity verification
Workmanship
Specifications
Labeling & claims
Packaging integrity
Services
Quality control, where it matters most.
Independent, on-site verification that gives you a clear view of your product and your supplier — before the next decision carries more risk.
Pre-shipment inspection
On-site product verification before goods leave the supplier — samples selected by AQL methodology, checked against your requirements, documented with photos.
- Randomized AQL sampling per ISO 2859-1
- Specification & packaging checks
- Photo-documented pass / fail report
Supplier qualification audit
A structured facility and quality-system audit against 21 CFR Part 111 and cGMP expectations — in the US and overseas.
- Facility & process assessment
- Scored findings report
- Corrective-action priorities
Production monitoring
Retained eyes on the factory floor for brands with ongoing production — issues surface while there’s still time to act.
- In-process observations
- Milestone & issue reporting
- Recurring on-site support
Quality system development
Complete quality management systems built from the ground up or brought up to standard — processes that hold up under audit.
- QMS design & implementation
- Document control & SOP management
- Returns & adverse event programs
Regulatory & label compliance
Label and claims review, product registrations and filings, and continuous monitoring as requirements change across markets.
- Label & marketing claims review
- Product registrations & filings
- Ongoing regulatory monitoring
Supplier quality & cost recovery
Supplier issues turned into documented recoveries — qualification, auditing, and deviation management with real dollars attached.
- Supplier qualification & auditing
- Deviation & complaint resolution
- Negotiated compensation recovery
How it works
From request to decision.
A straightforward field process, built to deliver usable evidence instead of another layer of uncertainty.
Book
Share the product, supplier, location, timing, and acceptance criteria.
Inspect
We go on site, select the sample, and verify what is actually being produced.
Get the report
A clear, photo-documented report within 48 hours of the inspection.
Decide confidently
Approve, hold, or request correction — with evidence behind the call.
The firm
An independent quality assurance firm for brands that can’t afford surprises.
Entity Pharma exists for one reason: to give brands a clear, evidence-backed view of what’s happening at their suppliers — before a shipment, before a launch, before a problem becomes a recall.
Independent by design
We don’t manufacture, broker, or take supplier commissions. Our only product is an honest answer — which is why brands trust the report even when it’s bad news.
Operator-grade rigor
Our methods come from running quality systems inside manufacturing operations — not from a checklist downloaded off the internet. Deviations, CAPAs, batch records: we’ve lived all of it.
Evidence, not opinion
Every finding is photo-documented and tied to a specification or standard. You get a report you can act on — and send to your supplier.
●SQF / NSF Practitioner
●PCQI Food Safety
●HACCP Certified
●US & Southeast Asia field experience
●Led by Marco A. Camacho, 10+ years quality leadership
Start a conversation
Have a product or supplier that needs a closer look?
Tell me where the facility is and when you need eyes on it. I’ll take it from there.