01
Identity
Does the record identify the material and the method used to characterize it?
For research, professional, and investigational evaluation only. No exosome product is FDA-approved for therapeutic use in humans.
Testing and traceability
Quality evidence should survive the handoff.
We organize evaluation around the product, lot, method, result and release decision—not around unqualified quality language.
02
Safety criteria
Do sterility and endotoxin entries show the named method, criterion and result?
03
Traceability
Can the product, lot, donor eligibility record and release document be reconciled?
04
Release
Is there an explicit decision that the reported results met the stated criteria?
Review framework
Five questions for every file.
| Question | What to verify | Why it matters |
|---|---|---|
| What is it? | Product name, form and identifier | Prevents document/product mismatch |
| Which lot? | Lot or batch number on the report | Connects the result to supplied material |
| How tested? | Named method and acceptance criterion | Makes the result interpretable |
| What result? | Actual value, conforming result or no-growth finding | Separates evidence from marketing |
| Who released it? | Issuer, reviewer and release decision | Clarifies accountability and document status |
Document hierarchy
Know what kind of record you are reading.
- Issuing laboratory reportThe original analytical record from the laboratory that performed the test.
- Manufacturer release recordA lot release decision that may incorporate multiple source records.
- Private-label summaryA compiled summary that should disclose that it does not replace the original record unless verified.
Documentation available
Start with the records.
Tell us what you are evaluating. We will match the request to the relevant current-batch documentation.