FDA 483 OBSERVATION · #338 OF 1,000 MOST-CITED
Ongoing verification - complaints, calibration records
FDA cited this observation 62 times across 58 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.9× the rate of the average FDA-cited firm (15.5% vs 8.3%), across 58 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
Your verification procedures do not include, at a minimum, ongoing verification activities including calibration of process monitoring instruments and review of monitoring, corrective action, and calibration records.
Your verification procedures do not include, at a minimum, ongoing verification activities including review of monitoring, corrective action, and calibration records.
Your verification procedures do not include, at a minimum, ongoing verification activities including review of monitoring, corrective action, and calibration records.
Your verification procedures do not include, at a minimum, ongoing verification activities including calibration of process monitoring instruments and review of monitoring, corrective action, and calibration records.
Your verification procedures do not include, at a minimum, ongoing verification activities including calibration of process monitoring instruments and review of monitoring, corrective action, and calibration records.
Your verification procedures do not include, at a minimum, ongoing verification activities including review of monitoring, corrective action, and calibration records.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.