FDA 483 OBSERVATION · #160 OF 1,923 MOST-CITED
Sanitation monitoring documentation
FDA cited this observation 193 times across 175 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.
Monitoring of the facility’s sanitation preventive controls was not documented as required — the records that show a sanitation control was checked at its planned frequency and found in control were missing, incomplete, or not made at the time of monitoring. This is the monitoring-records requirement of §117.145 as it applies to sanitation controls.
Why FDA writes it — Monitoring is what confirms a sanitation control is operating between verification checks; without contemporaneous monitoring documentation there is no evidence the control held, and a lapse that allowed environmental or allergen contamination would go undetected. FDA cites this because undocumented monitoring is indistinguishable from monitoring that never happened.
- Document each sanitation-control monitoring event with the date, time, control point, observation or measurement, and the monitor’s initials.
- Monitor at the frequency the food safety plan specifies and record the result at the moment of the check, not afterward.
- Flag any monitoring result that shows a loss of control and link it to the corrective-action record it triggered.
- Have a qualified individual review monitoring records within the required timeframe and sign to confirm the control stayed in control.
- Sanitation monitoring performed but recorded on scrap or from memory, so the documentation is incomplete or not contemporaneous.
- No defined monitoring form tied to each sanitation control, leaving frequency and content of records to individual judgment.
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 1.3× the rate of the average FDA-cited firm (9.7% vs 7.8%), across 175 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 sanitation control records do not accurately document the conditions or practices observed at your firm.
Your sanitation control records do not accurately document the conditions or practices observed at your firm.
Your sanitation control records do not accurately document the conditions or practices observed at your firm.
Your sanitation control records do not accurately document the conditions or practices observed at your firm.
Your sanitation control records do not accurately document the conditions or practices observed at your firm.
Your sanitation control records do not accurately document the conditions or practices observed at your firm.
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 →