FDA 483 OBSERVATION · #465 OF 1,000 MOST-CITED
Physical plant - clean and sanitary
FDA cited this observation 41 times across 37 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 maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.
You did not maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.
You did not maintain your physical plant in a clean and sanitary condition.
You did not maintain your physical plant in a clean and sanitary condition.
You did not maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.
You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.
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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