How to use this checklist
Use this as a purchasing and quality conversation guide. It does not replace reading Part 1271 or advice from regulatory counsel.
Store checklist results with the vendor packet so multi-site clinics can see what was verified and what remains open.
Donor and recovery questions
Ask how donor eligibility is documented, which serology panels are used, and how consent and recovery setting are described by the supplier.
If recovery is described as full-term C-section by licensed personnel, record that description and ask how exceptions are handled.
Processing, release, and testing
Ask for the sterility testing approach, quarantine-until-release practice, unique lot identifiers, and what appears on the certificate of analysis.
Confirm expiration dating and whether lyophilized and cryopreserved SKUs need different receiving SOPs.
Clinic-side controls
Define who may order, who receives, and who releases inventory. Marketing claims are not receiving criteria.
Escalate label mismatches before any release decision.
Frequently asked questions
Does Precision Biologics certify regulatory status for our use?+
No. Classification and intended-use determinations belong to the ordering physician and clinic counsel.
Is this legal advice?+
No. This is general information for licensed healthcare professionals.
Can account approval replace counsel review?+
No. Account verification is administrative only.
Does this page determine how we may use products discussed under 21 CFR 1271 clinic checklist?+
No. Intended use remains with the ordering physician and clinic counsel.