US FDA
21 CFR 211.198 - Complaint Files
Plain-language explanation, inspection context and common violation patterns.
What it says
Written procedures describing the handling of all written and oral complaints must be established and followed. The quality control unit must review any complaint involving a possible failure of a drug product to meet its specifications, and a written record must document whether an investigation was conducted and, if not, the reason and the name of the person responsible for the decision.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Any communication alleging a possible product defect qualifies as a complaint under this provision, regardless of how minor it initially appears or whether the allegation is later confirmed.
- A decision not to investigate a specific complaint is explicitly permitted, but only when documented with a defensible rationale on file - an undocumented judgment call does not satisfy this requirement.
- Quality unit review of quality-related complaints is a distinct, required step, separate from simply logging the complaint or responding to the complainant.
What FDA inspectors look for
- Whether every complaint alleging a possible product defect received documented quality unit review, including complaints that were ultimately determined not to require investigation.
- Whether complaint trend data is reviewed collectively across a product or manufacturing line, not just complaint by complaint.
- Whether complaints directly flagged by FDA itself were followed through to an actual investigation, not just logged and acknowledged.
Most common violation
A written complaint handling procedure exists, but a specific complaint, including one FDA itself has directly notified the firm about, is never investigated, or the decision not to investigate is never documented in the complaint file. This is a persistent enforcement pattern in both drug and device warning letters.
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