FDA 483 OBSERVATION · #53 OF 1,923 MOST-CITED
Food safety plan
FDA cited this observation 450 times across 404 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.
A facility required to have a written food safety plan under the FSMA preventive-controls rule did not have one, or it was inadequate — missing the hazard analysis, preventive controls, monitoring, corrective actions, or verification the rule requires.
Why FDA writes it — The food safety plan is the central FSMA document that ties the whole preventive-controls system together. Its absence or inadequacy means the facility cannot show it has systematically identified and controlled its hazards — a foundational failure under the Preventive Controls for Human Food rule.
- Prepare (or have prepared by a preventive-controls qualified individual) a written food safety plan.
- Include the hazard analysis, preventive controls, supply-chain program, recall plan, and the associated monitoring, corrective-action, and verification procedures.
- Keep the plan current and reanalyse it at least every three years or when a change warrants.
- Ensure it is signed and dated, and available for FDA review.
- The facility treated a HACCP or older food-safety document as sufficient without meeting the specific FSMA food-safety-plan requirements.
- The plan was written once and never reanalysed as products and processes changed.
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 1.9× the rate of the average FDA-cited firm (14.4% vs 7.8%), across 404 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 did not have a written food safety plan.
You did not have a written food safety plan.
You did not have a written food safety plan.
You did not have a written food safety plan.
You did not have a written food safety plan.
You did not have a written food safety plan.
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 →