FDA 483 OBSERVATION · #97 OF 1,923 MOST-CITED
Written procedures - product complaint
FDA cited this observation 300 times across 270 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Drug CGMP requires written procedures for the receipt, review, and evaluation of product complaints, including whether a complaint reflects a possible failure of the drug to meet specifications and whether it must be investigated. Device manufacturers face the parallel complaint-handling requirement at 21 CFR 820.198.
Why FDA writes it — FDA cites this when complaint-handling procedures are absent or inadequate, because complaints are an early warning system — without a controlled process to capture, evaluate, and investigate them, a firm misses the field signal that a product or process has failed.
- Establish written procedures defining how complaints are received, logged, reviewed, and evaluated for a possible specification or safety failure.
- Define criteria for when a complaint triggers a formal investigation and link it to your deviation/CAPA system.
- Maintain complaint files with the required findings and follow-up, and trend them to detect recurring issues.
- Complaints handled informally by customer service without a controlled written procedure or quality-unit review.
- No defined threshold for escalating a complaint into an investigation, so real signals are closed out as routine.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 3.9× the rate of the average FDA-cited firm (30.0% vs 7.8%), across 270 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish and follow written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →