21 CFR 111.553 requires the quality control function to review every complaint involving a possible failure of a dietary supplement to meet any specification, with a written record naming the product, batch/lot, complaint nature, response, and the investigation outcome. The file is reviewed every FDA supplement inspection and is the upstream feed to the DSHEA Title II 15-business-day serious AER clock when injury is reported.

Regulatory anchors

21 CFR 111.553
21 CFR 111.560

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Audits that change the next batch.

Checklist apps stop at the PDF. V5 keeps going — a failed line opens a non-conformance, optionally a CAPA, optionally a lot hold, optionally a supplier scorecard hit, optionally a training reassignment. The loop closes itself.

Related terms

Supplement Adverse Event Reporting