FDA 483 OBSERVATION · #901 OF 1,000 MOST-CITED
Identification of Persons Performing Significant Steps
FDA cited this observation 16 times across 16 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
The batch production and control records are deficient in that they do not include identification of persons supervising each significant step in the operation.
The batch production and control records are deficient in that they do not include identification of persons performing, supervising and checking each significant step in the operation.
The batch production and control records are deficient in that they do not include identification of persons each significant step in the operation.
The batch production and control records are deficient in that they do not include identification of persons each significant step in the operation.
The batch production and control records are deficient in that they do not include identification of persons performing and checking each significant step in the operation.
The batch production and control records are deficient in that they do not include identification of persons each significant step in the operation.
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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