FDA 483 OBSERVATION · #111 OF 1,000 MOST-CITED
Training--operations, GMPs, written procedures
FDA cited this observation 207 times across 195 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
Employees are not given training in current good manufacturing practices.
Employees are not given training in the particular operations they perform as part of their function.
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Employees are not given training in the particular operations they perform as part of their function.
Employees are not given training in current good manufacturing practices.
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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