FDA 483 OBSERVATION · #131 OF 1,000 MOST-CITED
Training , Education , Experience overall
FDA cited this observation 174 times across 165 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 engaged in the processing of a drug product lack the training required to perform their assigned functions.
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
Employees engaged in the packing of a drug product lack the education, training and experience required to perform their assigned functions.
Employees engaged in the processing of a drug product lack the training required to perform their 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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.