FDA 483 OBSERVATION · #133 OF 1,923 MOST-CITED
Process control - Foreign objects
FDA cited this observation 225 times across 216 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.
Controls intended to keep foreign objects out of food during processing were missing or inadequate — no metal detection, unguarded glass or brittle plastic near the line, shedding equipment, or no control over hardware and tools over open product. This maps to the processes-and-controls requirement of §117.80, and where the object is a hazard reasonably likely to occur, to the preventive control under §117.135.
Why FDA writes it — Foreign objects — metal, glass, hard plastic — are physical hazards that can cut, choke, or break teeth and are a leading cause of food recalls and injury complaints. FDA cites weak foreign-object control because these hazards are preventable at the process step and are unacceptable in finished food.
- Apply the relevant physical controls — metal detection or X-ray, magnets, screens, and a glass-and-brittle-plastic program — at the appropriate process points.
- Guard, inventory, and inspect equipment for parts, fasteners, and shedding that could enter open product, and control tools and hardware over the line.
- Set reject/acceptance criteria for detection equipment and record routine functional checks with known test pieces.
- Investigate every foreign-object finding or complaint to its source and correct the process condition that allowed it.
- Foreign-material control treated as a single detector at the end rather than a layered program across the whole process.
- No glass/brittle-plastic register or equipment-integrity inspection, so shedding and breakage go unnoticed until product is contaminated.
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 0.5× the rate of the average FDA-cited firm (3.7% vs 7.8%), across 216 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 take an adequate measure to protect against inclusion of metal or extraneous material in food.
You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
You did not take an adequate measure to protect against inclusion of metal or extraneous material in 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 →