What Should Be on a COA

A checklist for evaluating whether a supplier's documentation is complete — or quietly incomplete.

The Checklist

1. Lot number matching the physical vial — not a generic document ID.
2. Donor/source information — tissue type and origin, with applicable screening standards referenced.
3. Manufacturing facility identification — including an FDA facility registration number (FEI), not just a brand name.
4. Identity / characterization panel — confirming cell type via marker analysis, specific to the lot.
5. Viable cell count — an actual number, with the counting method listed (see How Stem Cell Counting Works).
6. Post-thaw viability percentage — measured after the freeze/thaw cycle, not before (see Why Post-Thaw Viability Matters).
7. Sterility results — with the test method and incubation period noted.
8. Cryopreservation medium — named specifically, matching what's actually in the vial.
9. Signed, dated release approval — a named individual with a stated title, not an unsigned template.

The Gap to Watch For

If a cell count or viability figure is present but not tied to a specific lot number, treat it as a marketing claim rather than a test result — it may describe a different batch, an average across batches, or a target specification rather than what's in the vial.

This page is educational reference material for licensed healthcare providers and does not constitute medical, legal, or regulatory advice. HCT/P products are not FDA-approved.