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FDA 483 OBSERVATION · #1649 OF 1,916 MOST-CITED

Measurements with tap water container

FDA cited this observation 6 times across 6 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.

BY PROGRAM AREA
Radiologic Health6
BY FISCAL YEAR
FY20231
FY20181
FY20171
FY20163

How FDA worded it — real examples

Microwave oven measurements were not made with the microwave oven containing a load of 275 ± 15 milliliters of tap water initially at 20 ± 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

SMEG S.p.A. · Guastalla · Radiologic Health · 2023-05-11

Microwave oven measurements were not made with the microwave oven containing a load of 275 ± 15 milliliters of tap water initially at 20 ± 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

Miele & Cie. KG · Oelde · Radiologic Health · 2018-04-19

Microwave oven measurements were not made with the microwave oven containing a load of 275 ± 15 milliliters of tap water initially at 20 ± 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

Turbochef Technologies Inc · Carrollton, Texas · Radiologic Health · 2017-03-28

Microwave oven measurements were not made with the microwave oven containing a load of 275 ? 15 milliliters of tap water initially at 20 ? 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

Teka Portugal S.A. · Ilhavo · Radiologic Health · 2016-05-06

Microwave oven measurements were not made with the microwave oven containing a load of 275 ? 15 milliliters of tap water initially at 20 ? 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

Sharp U.K. Manufacturing (SUKM) · Wrexham · Radiologic Health · 2016-05-03

Microwave oven measurements were not made with the microwave oven containing a load of 275 ? 15 milliliters of tap water initially at 20 ? 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer.

Welbilt U.K. Ltd · Sheffield · Radiologic Health · 2016-04-27

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.

Medical devices

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →