FDA 483 OBSERVATION · #678 OF 1,932 MOST-CITED
Electronic records
FDA cited this observation 32 times across 32 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 is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.2× the rate of the average FDA-cited firm (9.4% vs 7.8%), across 32 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
Electronic records are used, but they do not meet systems validation, system access limitation, operational system check, device check, personnel qualifications, employee accountability/responsibility policy, signature manifestation and signature to record linking requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Electronic records are used, but they do not meet system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Electronic records are used, but they do not meet system access limitation, audit trail, employee accountability/responsibility policy and systems documentation control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Electronic records are used, but they do not meet system access limitation and authority check requirements to ensure that they are trustworthy, reliable and generally equivalent to paper 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. Open the 483 observation explorer →