FDA 483 OBSERVATION · #148 OF 1,923 MOST-CITED
Registration
FDA cited this observation 206 times across 195 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.
Facilities that manufacture, process, pack, or hold food for U.S. consumption must register with FDA as a food facility and keep that registration current, including the biennial renewal — the baseline that makes a facility known to FDA and subject to inspection.
Why FDA writes it — FDA cites this when a facility is unregistered, registered under wrong information, or has not renewed, because an unregistered facility operates outside FDA’s visibility — food can move to market from a site the agency cannot track, inspect on schedule, or reach in a recall.
- Register the facility with FDA before it begins manufacturing, processing, packing, or holding food, and obtain a registration number.
- Renew the registration during each biennial renewal period and update it within the required timeframe when information changes.
- Keep the registration record and contact/agent information accurate and retrievable for inspection.
- Missing the biennial renewal window, which automatically expires the registration.
- Registration details (owner, address, agent, activities) not updated after a change, leaving FDA’s record wrong.
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× the rate of the average FDA-cited firm (7.7% vs 7.8%), across 195 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 register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
You did not register with FDA with required information on Form FDA 2541 (food canning establishment registration) within 10 days after first engaging in the manufacture, processing, and packaging a low-acid canned 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 →