FDA 483 OBSERVATION · #687 OF 1,000 MOST-CITED
Written procedures describing in detail
FDA cited this observation 24 times across 22 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
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination and testing of labeling and packaging materials.
There is a lack of written procedures describing in sufficient detail the handling of labeling and packaging materials.
There is a lack of written procedures describing in sufficient detail the identification, storage, handling and examination of labeling and packaging materials.
There is a lack of written procedures describing in sufficient detail the receipt, sampling and examination of labeling and packaging materials.
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination and testing of labeling and packaging materials.
There is a lack of written procedures describing in sufficient detail the examination of labeling and packaging materials.
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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