Dietary Supplement Reprocessing: What Quality Control Must Document
Reprocessing is not a routine way to release a nonconforming supplement. Part 111 requires material review, a documented disposition decision, and applicable quality-control approval.
Define the problem before selecting a treatment
Part 111 addresses material review when specifications are not met or when deviations or unanticipated occurrences arise. The review should establish what happened and support a disposition decision. Repeating a test or proposing a blending step does not, by itself, resolve whether the product can be used.
Sections 111.77, 111.87, 111.90 and 111.113 should be read together for the situation. The rules distinguish rejection from circumstances in which quality-control personnel may approve a treatment, in-process adjustment, or reprocessing. They do not create a blanket permission to salvage any failed batch.
Connect the decision to the manufacturing evidence
A practical review file can bring together the affected material and batch identifiers, the unmet specification or event, the investigation information, the proposed action, its scientific basis, and the quality-control disposition. These are organizing suggestions; the actual required records are set out in Part 111.
- Identify all material and lots within the reviewed scope.
- Preserve the original test results and deviation information.
- Document why the proposed action is appropriate for that situation.
- Link execution records to the approved decision.
- Verify applicable specifications and obtain the required release approval.
Approval and verification are separate steps
Part 111 states that a reprocessed batch, or a batch containing treated or adjusted components, must meet the applicable requirements and receive quality-control approval before distribution. An authorization to attempt an action is not the same as the later decision to release the resulting batch.
Keep both decisions visible. An outside consultant’s recommendation, a customer’s acceptance, or a production deadline should not be described as replacing the regulatory role of quality-control personnel.
Questions for a mock inspection
Can the team show the original problem without editing it away? Can it trace the approved action into the executed record? Is the eventual disposition supported by the relevant results? Can it identify the person who made the required quality-control decision? A clear trace is more useful than an unsupported statement that reprocessing was validated.
Related inspection resources
- Reserve samples for investigations
- What to expect during a supplement inspection
- Dietary supplement inspection consulting
Primary sources
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.