FDA 483 OBSERVATION · #110 OF 1,923 MOST-CITED
Code - required elements
FDA cited this observation 272 times across 260 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 low-acid canned food, containers did not bear the permanent, legible identifying code with all required elements — the code that identifies the establishment, the product, the year, day, and period of packing was missing, incomplete, or not permanently and legibly marked as §113.60(c) requires.
Why FDA writes it — The container code is what makes a targeted recall possible; without a complete, legible code, a specific lot of potentially under-processed LACF cannot be traced and removed, forcing far broader market action and leaving unsafe product in commerce. FDA cites this because lot identification is essential to containing a botulism-risk failure.
- Mark every container with a permanent, legible code that encodes the establishment, product, and the year, day, and period (or interval) of packing.
- Verify code legibility and completeness at start-up and periodically during the run, and record the check.
- Maintain a key that decodes the marking so investigators and the facility can translate a code to a specific production lot.
- Correlate the container code to the scheduled-process and production records so any coded lot ties back to its actual processing data.
- Coding equipment drifting to illegible or partial marks without an in-line legibility check to catch it.
- Code content that omits a required element because the coding standard was set for retail convenience, not the LACF regulation.
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 0.8× the rate of the average FDA-cited firm (6.2% vs 7.8%), across 260 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
Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein.
Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period.
Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein.
Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period.
Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year and date.
Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year and date.
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 →