FDA 483 OBSERVATION · #519 OF 1,000 MOST-CITED
Inadequate number of personnel
FDA cited this observation 36 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
The number of qualified personnel is inadequate to perform and supervise the manufacture and processing of each drug product.
The number of qualified personnel is inadequate to perform the manufacture of each drug product.
The number of qualified personnel is inadequate to perform and supervise the manufacture of each drug product.
The number of qualified personnel is inadequate to perform the manufacture of each drug product.
The number of qualified personnel is inadequate to supervise the packing of each drug product.
The number of qualified personnel is inadequate to perform and supervise the manufacture, processing and packing of each drug product.
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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