FDA 483 OBSERVATION · #315 OF 1,000 MOST-CITED
Lack of or inadequate In-process acceptance procedures
FDA cited this observation 68 times across 66 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
Procedures for the acceptance and control of in-process product have not been established.
Procedures for the acceptance of in-process product have not been adequately established.
Procedures for the acceptance of in-process product have not been adequately established.
Procedures for the of in-process product have not been established.
Procedures for the acceptance and control of in-process product have not been adequately established.
Procedures for the acceptance of in-process product have not been adequately established.
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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