21 CFR 606.160 - Records - Blood and Blood Components

What it says

Records must be maintained for blood and blood component collection, processing, testing, storage and distribution in sufficient detail to permit tracing of each unit from its source through final disposition, retained for a defined period and readily available for review.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Because a single donor's blood can be separated into multiple components distributed to different recipients, traceability records under this provision have to support tracing in both directions, from donor to every resulting component, and from any distributed component back to its donor.
• This traceability requirement is what makes lookback investigations possible when a post-donation concern arises about a specific donor, connecting recordkeeping directly to patient safety response capability, not just routine compliance.
• Records supporting donor eligibility determinations must be retained and cross-referenced with the specific units collected from that donor, linking this provision closely to donor screening and testing requirements elsewhere in the blood regulations.

What FDA inspectors look for

• Whether records allow complete tracing of a blood unit from donor collection through every resulting component's final disposition.
• Whether donor eligibility records are correctly linked to the specific units collected, supporting an effective lookback process if needed.
• Whether record retention periods and accessibility meet the standard needed to support a timely traceability investigation.

Related regulations