FDA 483 OBSERVATION · #297 OF 1,000 MOST-CITED
Procedures To Be in Writing
FDA cited this observation 72 times across 72 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
Written procedures are lacking which describe in sufficient detail the receipt, testing, approval and rejection of components and drug product containers.
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures.
Written procedures are lacking which describe in sufficient detail the approval and rejection of components.
Written procedures are lacking which describe in sufficient detail the testing of components.
Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures.
Written procedures are lacking which describe in sufficient detail the storage of components.
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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