FDA 483 OBSERVATION · #646 OF 1,000 MOST-CITED
Personnel - quality control personnel - qualified
FDA cited this observation 27 times across 25 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 personnel you identified to perform quality control operations are not qualified to do so and do not have the education, training or experience to perform the assigned functions.
The personnel you identified to perform quality control operations are not qualified to do so and do not have the education, training or experience to perform the assigned functions.
The personnel you identified to perform quality control operations do not have the education, training or experience to perform the assigned functions.
The personnel you identified to perform quality control operations do not have the education, training or experience to perform the assigned functions.
The personnel you identified to perform quality control operations are not qualified to do so and do not have the education, training or experience to perform the assigned functions.
The personnel you identified to perform quality control operations are not qualified to do so and do not have the education, training or experience to perform the assigned functions.
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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