FDA 483 OBSERVATION · #115 OF 1,923 MOST-CITED
Not washed/sanitized when appropriate
FDA cited this observation 259 times across 248 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 means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Utensils and equipment food-contact surfaces were not cleaned and sanitized at a frequency adequate to protect against contamination — surfaces were left uncleaned between uses, across changeovers, or after periods that allowed residue and microbial buildup.
Why FDA writes it — Food-contact surfaces that are not cleaned and sanitized when needed accumulate residue and biofilm that inoculate the next batch; frequency is the control, because a surface clean at start of shift can become a contamination source hours later.
- Set cleaning and sanitizing frequencies for each food-contact surface based on soil load, product type, and run time.
- Sanitize food-contact surfaces after cleaning, at changeovers, and after any event that could contaminate them.
- Verify sanitation effectiveness with visual checks, ATP, or environmental swabs and record the results.
- Correct and re-clean when a surface fails inspection, and trend recurring failures to their cause.
- Cleaning frequencies are generic rather than set to the actual soil and microbial load of each surface.
- Cleaning is verified by completion of a checklist rather than by confirming the surface is actually clean and sanitized.
How to close this finding — and stop it recurring
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 (9.7% vs 7.8%), across 248 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. Open the 483 observation explorer →