FDA 483 OBSERVATION · #504 OF 1,000 MOST-CITED
Hold - mix-up, contamination, deterioration
FDA cited this observation 38 times across 31 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 held components under conditions that lead to mix-up, contamination, or deterioration.
You held components and dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held dietary supplements under conditions that lead to mix-up, contamination, or deterioration.
You held components, dietary supplements and labels under conditions that lead to mix-up, contamination, or deterioration.
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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