FDA 483 OBSERVATION · #50 OF 1,923 MOST-CITED
Sanitation Records
FDA cited this observation 492 times across 452 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.
The facility could not produce complete, contemporaneous records showing that its sanitation activities and sanitation preventive controls were actually performed and monitored. This spans the sanitary-operations recordkeeping of Subpart B (§117.35) and the monitoring records that a sanitation preventive control requires under §117.145, held per the recordkeeping rules of Subpart F.
Why FDA writes it — Sanitation only counts if it is documented — an inspector cannot confirm that food-contact surfaces were cleaned, that a sanitizer was at concentration, or that a control was monitored without a signed, dated record. FDA cites missing sanitation records because absent documentation is treated as an activity that did not happen, leaving cross-contamination and allergen hazards unverified.
- Create sanitation monitoring records that capture the date, the surface or line, the activity, the result or measurement, and the initials of the person performing it, at the frequency the plan requires.
- Have a qualified individual review and sign sanitation records within the required window to confirm the activity was done and any deviation handled.
- Retain sanitation records for the required period on-site and make them retrievable within the timeframe an inspector or auditor expects.
- Reconcile the record set against the master sanitation schedule so every scheduled task has a matching completed record.
- Sanitation performed by habit and verbal handoff, with no standardized form that forces the who/when/what/result to be captured at the time of the task.
- No records-review step, so gaps and back-dated entries are never caught until an inspector pulls the file.
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 (10.2% vs 7.8%), across 452 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
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.
You are not maintaining sanitation control records that document monitoring for maintenance of hand washing, hand sanitizing, and toilet facilities, proper labeling, storage and use of toxic chemicals and control of employee health conditions.
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions and exclusion of pests.
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 →