Glossary
Complaint Handling
The procedure for receiving written and oral complaints about a product, reviewing them, deciding whether investigation is needed, and keeping the record.
Details
What is regulated is not the fact that a complaint arrived but the procedure for handling it, and the regulation requires three judgements: whether the quality control unit reviewed it, whether an investigation under 21 CFR 211.192 is required, and whether it represents a serious and unexpected adverse drug experience that must be reported to the authority. Where the decision is not to investigate, the reason for that decision must also be recorded. The corpus cites inadequate complaint handling procedures, procedures that were established but not followed, and cases where the procedure did not exist at all alongside quarantine and change control gaps.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your QU failed to ensure the following: • Establishment of adequate procedures describing complaint handling, change control, and…
FDA · FDA Warning Letter · 2024-10-01 -
Complaint Handling Your QU did not adequately ensure procedures were established and followed.
FDA · FDA Warning Letter · 2026-08-18 -
For example, you failed to ensure: An adequate complaint handling process (21 CFR 211.198)…
FDA · FDA Warning Letter · 2023-08-01
