A supplier audit works through the chain from recovery to release: how donor tissue was recovered and by whom, how long it sat before processing, what sterility and other testing was performed, and whether the lot was held in quarantine until release criteria were met. For cryopreserved products, the audit also covers freezing method and storage temperature, since a cold chain failure at any point can affect the tissue regardless of how the lot was originally tested.
If a supplier describes its processing as following FDA regulations and AATB or AABB guidelines, treat that description as a starting point for an audit, not a substitute for one. Ask whether the statement reflects internal practice, third-party accreditation, or neither, and request the underlying lot release record and donor eligibility summary rather than accepting a general compliance statement. Independent verification of what is actually documented matters more than the wording a supplier chooses to use.
FDA's HCT/P enforcement-discretion period ended May 31, 2021. Review current product-specific requirements with counsel. A fresh audit is worth repeating when a clinic adds a new product line, after any reported temperature excursion, or when a supplier's marketing claims shift in a way that no longer matches its documentation.
A current supplier audit gives the clinic its own record that the products it stocks are backed by real testing and traceability, not only by a supplier's description of its process.