FDA 483 OBSERVATION · #145 OF 1,923 MOST-CITED
Safety lighting and glass
FDA cited this observation 207 times across 206 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.
Light bulbs, fixtures, skylights, and other glass or brittle-material items suspended over exposed food were not shatter-resistant or otherwise protected to prevent contamination of food in case of breakage. Safety-type lighting or glass protection was missing.
Why FDA writes it — A shattered bulb or pane over an open product line contaminates food with glass — a hard, sharp foreign material that can injure consumers and triggers recalls; safety lighting and glass shielding contain the fragments before they reach product.
- Install shatter-resistant bulbs or protective shields, sleeves, or covers on all lighting over exposed product and food-contact surfaces.
- Protect skylights, windows, and other overhead glass or brittle items against breakage above product zones.
- Maintain a glass-and-brittle-plastic register and inspect listed items on a defined schedule.
- Have a written breakage response procedure to isolate and dispose of potentially affected product.
- Standard bulbs and fixtures are installed during construction or replacement without switching to shatter-resistant types.
- No glass-and-brittle-plastic control program exists, so overhead glass hazards are never systematically identified.
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 1.2× the rate of the average FDA-cited firm (9.2% vs 7.8%), across 206 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 safety-type light bulbs suspended over exposed food.
Failure to provide safety-type light bulbs suspended over exposed food.
Failure to provide safety-type light bulbs suspended over exposed food.
Failure to provide safety-type lighting fixtures suspended over exposed food.
Failure to provide safety-type light bulbs and lighting fixtures suspended over exposed food.
Failure to provide safety-type light bulbs suspended over exposed 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 →