FDA 483 OBSERVATION · #122 OF 1,923 MOST-CITED
Maintenance of processing and production records
FDA cited this observation 253 times across 224 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 thermally processed low-acid canned food, processing and production records were not maintained as required — retort time/temperature charts, initial temperatures, critical-factor readings, and closure examinations were incomplete, not made at the time of processing, or not retained. This is the records requirement of §113.100 for scheduled-process operations.
Why FDA writes it — Processing records are the only proof that each lot actually received its scheduled thermal process; without contemporaneous, complete records a facility cannot show a lot was commercially sterile, and any doubt must be treated as under-processed. FDA cites this because these records are the evidentiary backbone of LACF safety and recall traceability.
- Record actual retort time and temperature, initial temperature, and vent schedule for every load, entered by the operator at the time of processing.
- Log the critical factors the scheduled process depends on (fill, headspace, container size, consistency) for each production run.
- Have a qualified person review processing records against the scheduled process promptly and document the review and any deviation.
- Retain processing and production records for the required period and keep them retrievable and tied to container codes.
- Records back-filled or completed after the run rather than at the moment of processing, breaking their evidentiary value.
- No timely records-review step, so a deviation from the scheduled process is discovered only when an inspector reads the charts.
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 0.6× the rate of the average FDA-cited firm (4.5% vs 7.8%), across 224 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 maintain processing records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to 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 →