FDA 483 OBSERVATION · #214 OF 1,000 MOST-CITED
Not washed/sanitized when appropriate
FDA cited this observation 109 times across 105 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 1.4× the rate of the average FDA-cited firm (11.4% vs 8.3%), across 105 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
Employees did not wash hands thoroughly in an adequate hand-washing facility after each absence from the work station.
Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Employees did not wash hands thoroughly in an adequate hand-washing facility before starting work and after each absence from the work station.
Employees did not wash hands thoroughly in an adequate hand-washing facility after each absence from the work station.
Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work.
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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