FDA 483 OBSERVATION · #837 OF 1,000 MOST-CITED
Components - contamination, deterioration, mix-ups
FDA cited this observation 18 times across 18 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 hold components under conditions that will protect against contamination.
You did not hold components under conditions that will avoid mix-ups.
You did not hold components under conditions that will protect against contamination.
You did not hold components under conditions that will protect against contamination and avoid mix-ups.
You did not hold components under conditions that will avoid mix-ups.
You did not hold components under conditions that will protect against contamination.
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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