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.
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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