The Biologics Supplier Vetting Checklist

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This is an educational checklist, not legal or regulatory advice. Rules change and vary by state. Review your sourcing decisions with your own counsel and compliance advisor.

When you put a supplier's product in front of a patient, you are the one who has to stand behind where it came from. Send every supplier these questions in writing and keep their answers on file. A good supplier answers quickly and sends documents.

ARegistration and accreditation

1. Is the processing facility registered with the FDA as an HCT/P establishment? Ask for the FEI number and look it up in the FDA's public HCT/P establishment registration database.
2. Is the tissue bank accredited by the American Association of Tissue Banks (AATB)? Accreditation is voluntary, but it means an outside body inspects the bank against published standards. Ask for the current certificate and its expiration date.
3. Do they hold the licenses your state requires? Some states, including New York, California and Maryland, require a separate tissue bank license or permit. Ask for theirs if your state is one of them.
4. Who actually makes the product, and who are you buying from? The tissue bank, the manufacturer and the distributor can be three different companies. Get the name of each one in the chain.

BDonor eligibility and testing

5. Is a donor eligibility determination made for every donor? 21 CFR 1271 Subpart C requires one, made by a responsible person the establishment designates. Ask who that is.
6. What is each donor tested for, and where? Infectious disease testing should be done in a CLIA-certified lab using FDA-licensed, approved or cleared donor screening tests.
7. Will the donor eligibility summary come with your lot? The regulations require a summary of the records used to make the determination to accompany the product.

CProcessing and quality

8. Do they follow current good tissue practice (21 CFR 1271 Subpart D)? Ask when the FDA last inspected them, whether they received a Form 483 with observations, and whether you can see their response.
9. Does every lot come with a certificate of analysis? Check what it covers: sterility and endotoxin at a minimum, plus cell counts or viability if they make claims about either.
10. How is the product processed? Ask them to explain it in plain terms. You want to understand whether the tissue stays "minimally manipulated" under the FDA's definition.
11. What is the shelf life, and how was it set? Ask what data supports the expiration date on the label.

DRegulatory positioning

This section matters most. A product regulated only under section 361 of the Public Health Service Act has to meet every criterion in 21 CFR 1271.10(a):

• It is minimally manipulated.
• It is intended for homologous use only, meaning it does the same basic job in the recipient that the tissue did in the donor.
• It is not combined with another article, with narrow exceptions such as water, crystalloids or a sterilizing, preserving or storage agent.
• It either has no systemic effect and does not depend on the metabolic activity of living cells for its primary function, or it is for autologous use, use in a first- or second-degree blood relative, or reproductive use.

12. On what basis do they say this product is a 361 HCT/P? Ask them to walk you through each criterion above for this specific product.
13. What intended use is on the label and instructions for use? If the use you are planning doesn't match it, ask why they think it still qualifies.
14. Does their marketing promise to treat or cure specific diseases? Treat that as a red flag. The FDA judges a product's intended use partly from how it is advertised, and patients will hold you to whatever claims you repeat.
15. Does anyone call the product "FDA approved"? HCT/Ps regulated only under section 361 do not go through FDA premarket approval. A supplier who says otherwise is either confused about the rules or counting on you to be.

EStorage, shipping and traceability

16. What storage does the product need, and do you have it? Confirm the temperature range and whether you need a freezer or cryogenic storage on site.
17. How do they validate shipping? Ask what happens when a shipment arrives outside its temperature range, and who pays for the replacement.
18. Can every unit be traced from donor to patient? You will need lot and unit numbers in the chart. Ask what tracking records they expect you to keep and return.
19. How do you report an adverse reaction, and to whom? Establishments have to investigate certain adverse reactions and report them to the FDA. Get a named contact.
20. What is their recall process? Ask how you would be notified and how fast.

FCommercial terms

21. Do they sell only to licensed practitioners, and will they put all of the above in writing? A supplier that sells direct to consumers, or won't document its answers, is not one you want your name next to.