← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #242 OF 1,000 MOST-CITED

Personal food/drink/tobacco

FDA cited this observation 122 times across 122 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.

BY PROGRAM AREA
Foods122
BY FISCAL YEAR
FY20201
FY20191
FY201824
FY201758
FY201638

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.4× the rate of the average FDA-cited firm (10.7% vs 7.7%), across 122 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.

CHECKING ACCESS

Checking your Professional access…

How FDA worded it — real examples

Employees were observed to be drinking beverages in areas where food is exposed.

Haydel Enterprises Inc · Jefferson, Louisiana · Foods · 2019-11-14

Employees were observed to be drinking beverages in areas where.

Mamane Street Bakery · Kamuela, Hawaii · Foods · 2018-11-29

Employees were observed to be drinking beverages in areas where food is exposed.

Ambros Tinong's Bakery · Tamuning, Guam · Foods · 2018-08-06

Employees were observed to be drinking beverages in areas where food is exposed.

Redi Peel Potatoes, Inc. · Manchester, New Hampshire · Foods · 2018-06-12

Employees were observed to be eating food in areas where food is exposed.

Walker Enterprises, Inc. · Lynnwood, Washington · Foods · 2018-06-08

Employees were observed to be eating food and drinking beverages in areas where food is exposed and equipment or utensils are washed.

O.T.R.B. Co · Bozeman, Montana · Foods · 2018-05-04

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.

Food industry

Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →