FDA 483 OBSERVATION · #483 OF 1,000 MOST-CITED
Records - not signed and dated by qualified individual
FDA cited this observation 39 times across 34 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 1.1× the rate of the average FDA-cited firm (8.8% vs 8.3%), across 34 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 review of critical control point monitoring records and periodic end-product or in-process testing records are not signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
Your review of critical control point monitoring records, calibration records and periodic end-product or in-process testing records are not performed, signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
Your review of critical control point monitoring records are not performed, signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
Your review of are not signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
Your review of critical control point monitoring records, corrective action records, calibration records and periodic end-product or in-process testing records are not performed, signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
Your review of critical control point monitoring records are not performed, signed and dated by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience.
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.
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