FDA 483 OBSERVATION · #45 OF 1,923 MOST-CITED
Screening
FDA cited this observation 523 times across 508 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.
The facility did not adequately screen incoming ingredients, in-process material, or the process stream for foreign material — sieves, magnets, sifters, filters, or metal detection were missing, undersized, or not functioning. In this dataset the dominant home is human-food CGMP processes and controls (§117.80), where physical-hazard screening lives; LACF venting/screening findings instead belong to Part 113, but most “Screening” observations here are general foreign-material controls.
Why FDA writes it — Unscreened material lets metal fragments, glass, plastic, stones, or pests reach the finished product, which is a physical hazard that can injure consumers and trigger a Class I recall. FDA cites this because foreign-material screening is a front-line control that protects the food from contamination that later steps cannot remove.
- Install and specify screening devices — sifters, magnets, screens, filters, or metal detection — at the points in the process where foreign material is reasonably likely to enter.
- Define acceptance criteria (mesh size, magnet gauss/pull test, detector reject sensitivity) and record routine checks of each device against those criteria.
- Document what is captured on the screens or magnets and investigate any unusual accumulation as a signal of upstream contamination.
- Train operators on device inspection frequency and on the corrective action when a screen tears, a magnet is bypassed, or a detector fails a check.
- Screening devices treated as optional equipment rather than a hazard-analysis control, so no check frequency or acceptance limit was ever established.
- No routine verification that magnets, sieves, or detectors remain intact and effective between preventive-maintenance cycles.
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 0.9× the rate of the average FDA-cited firm (7.1% vs 7.8%), across 508 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
Failure to provide adequate screening or other protection against pests.
Failure to provide adequate screening or other protection against pests.
Failure to provide adequate screening or other protection against pests.
Failure to provide adequate screening or other protection against pests.
Failure to provide adequate screening or other protection against pests.
Failure to provide adequate screening or other protection against pests.
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 →