FDA 483 OBSERVATION · #639 OF 1,000 MOST-CITED
Personnel - quality control operations; identified
FDA cited this observation 27 times across 26 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
You have not identified personnel to be responsible for your quality control operations.
You have not identified personnel to be responsible for your quality control operations.
You have not identified personnel to be responsible for your quality control operations.
You have not identified personnel to be responsible for your quality control operations.
You have not identified personnel to be responsible for your quality control operations.
You have not identified personnel to be responsible for your quality control operations.
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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