FDA 483 OBSERVATION · #738 OF 1,000 MOST-CITED
Equipment - design - appropriate and suitable
FDA cited this observation 22 times across 22 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.
How FDA worded it — real examples
You did not use equipment or utensils of appropriate design and suitable for its intended use.
You did not use equipment or utensils of appropriate construction and that are properly maintained.
You did not use equipment or utensils suitable for its intended use.
You did not use equipment or utensils that are properly maintained.
You did not use equipment or utensils that are properly maintained.
You did not use equipment or utensils of appropriate workmanship and that are properly maintained.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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