FDA 483 OBSERVATION · #915 OF 1,000 MOST-CITED
Personnel - qualifications
FDA cited this observation 15 times across 15 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
Personnel engaged in manufacturing, packaging, labeling, holding and performing quality control operations for dietary supplements are not qualified to do so.
Personnel engaged in manufacturing, packaging, labeling, holding and performing quality control operations for dietary supplements are not qualified to do so.
Personnel engaged in labeling, holding and performing quality control operations for dietary supplements are not qualified to do so.
Personnel engaged in performing quality control operations for dietary supplements are not qualified to do so.
Personnel engaged in performing quality control operations for dietary supplements are not qualified to do so.
Personnel engaged in manufacturing, packaging, labeling, holding and performing quality control operations for dietary supplements are not qualified to do so.
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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