FDA 483 OBSERVATION · #502 OF 1,000 MOST-CITED
Written Procedures Not Followed
FDA cited this observation 38 times across 35 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 not followed for the approval of components.
Written procedures are not followed for the approval of components.
Written procedures are not followed for the receipt of drug product containers.
Written procedures are not followed for the storage and handling of components.
Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures.
Written procedures are not followed for the approval 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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