FDA 483 OBSERVATION · #118 OF 1,923 MOST-CITED
Scheduled process
FDA cited this observation 259 times across 240 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.
For a low-acid canned food, the thermal scheduled process was not established, on file, or followed as required — the process delivering commercial sterility was not developed by a competent processing authority, or the facility operated to a process that was never properly established under §113.83.
Why FDA writes it — The scheduled process is the calculated heat treatment that destroys Clostridium botulinum spores in a hermetically sealed low-acid food; without a validly established process, under-processing can leave viable spores and produce a deadly botulinum toxin. FDA cites this because the scheduled process is the core safety control of the entire LACF regulation.
- Have a competent processing authority establish the scheduled process for each product, container, and retort configuration, and keep the study on file.
- Document the critical factors (initial temperature, fill weight, consistency, headspace, container size) that the scheduled process depends on.
- Operate to the established process exactly and record actual time and temperature for every retort load.
- Refer any proposed change in product, container, or equipment back to the processing authority before running it.
- Reliance on an informal or inherited process that was never formally established or documented by a processing authority.
- Critical factors that the scheduled process assumes drifting in production without recognition that they invalidate the process.
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 0.7× the rate of the average FDA-cited firm (5.4% vs 7.8%), across 240 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
Acidified food is not manufactured in accordance with the scheduled process.
Acidified food is not manufactured in accordance with the scheduled process.
Acidified food is not manufactured in accordance with the scheduled process.
Acidified food is not manufactured in accordance with the scheduled process.
Acidified food is not manufactured in accordance with the scheduled process.
Acidified food is not manufactured in accordance with the scheduled process.
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 →