FDA 483 OBSERVATION · #41 OF 1,923 MOST-CITED
Process filing
FDA cited this observation 562 times across 482 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 processor of thermally processed low-acid foods in hermetically sealed containers did not file its scheduled processes with FDA as required, or operated without an established scheduled process — a specific requirement for LACF/acidified-food safety.
Why FDA writes it — For low-acid canned foods, the scheduled process (validated by a process authority) is the control that prevents Clostridium botulinum. Failing to establish or file it means the lethal process controlling a deadly hazard is not on record with FDA — a serious, category-specific violation.
- Establish scheduled processes for each low-acid food, container size, and processing method, determined by a qualified process authority.
- File the scheduled processes with FDA as required for low-acid canned foods.
- Register the establishment and operate under the filed scheduled process, with the required process controls and records.
- Refile or reassess when the product, container, or process changes.
- Operating without a scheduled process established by a process authority.
- Changing product/container/process without refiling the scheduled 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 (5.6% vs 7.8%), across 482 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 provide FDA with information on the scheduled process for a new acidified food before packing the food.
You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
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 →