FDA 483 OBSERVATION · #949 OF 1,000 MOST-CITED
Records - receiving; components, packaging, labels, products
FDA cited this observation 14 times across 14 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 make and keep receiving records for packaging and labels.
You did not make and keep receiving records for components, packaging, labels and products you received for packaging or labeling as a dietary supplement.
You did not make and keep receiving records for components, packaging and labels.
You did not make and keep receiving records for components, packaging and labels.
You did not make and keep receiving records for components, packaging, labels and products you received for packaging or labeling as a dietary supplement.
You did not make and keep receiving records for components, packaging, labels and products you received for packaging or labeling as a dietary supplement.
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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