FDA 483 OBSERVATION · #765 OF 1,000 MOST-CITED
Personnel - hygienic practices
FDA cited this observation 21 times across 20 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
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
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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