FDA 483 OBSERVATION · #151 OF 1,923 MOST-CITED
Process adherence
FDA cited this observation 205 times across 196 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.
Processing operations for low-acid canned food did not adhere to the established scheduled process — retort operating procedures, venting, come-up time, initial-temperature limits, or the actual time/temperature delivered departed from what the scheduled process specifies. This is the operating-conduct requirement of §113.87.
Why FDA writes it — Even a correctly established scheduled process fails to deliver commercial sterility if the retort is not operated to it — a short vent, low initial temperature, or truncated process time can leave viable C. botulinum spores. FDA cites process adherence because the safety of every LACF lot depends on the process being executed exactly as established, load after load.
- Operate each retort strictly to the scheduled process, including come-up, venting, process time and temperature, and cooling.
- Enforce initial-temperature and other critical-factor limits before starting a cycle, and hold product that starts outside them.
- Have qualified retort operators and supervisors trained and evidenced as competent to run the scheduled process.
- Detect any departure from the scheduled process, segregate the affected containers, and evaluate them under an established deviation procedure before release.
- Operator shortcuts (short vents, early start below initial temperature) tolerated because throughput was prioritized over the scheduled process.
- No systematic comparison of the actual delivered process against the scheduled process, so deviations are neither caught nor dispositioned.
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 1.1× the rate of the average FDA-cited firm (8.2% vs 7.8%), across 196 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 process each low-acid canned food in conformity with at least the filed scheduled processes and modifications.
You did not process each low-acid canned food in conformity with at least the filed scheduled processes and modifications.
You did not process a food in conformity with at least the scheduled process filed with FDA.
You did not process a food in conformity with at least the scheduled process filed with FDA.
You did not process a food in conformity with at least the scheduled process filed with FDA.
You did not process each low-acid canned food in conformity with at least the filed scheduled processes and modifications.
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 →