FDA 483 OBSERVATION · #750 OF 1,000 MOST-CITED
Records of risk management activities in product realization not maintained
FDA cited this observation 21 times across 21 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
Records of risk management activities in product realization were not maintained.
Records of risk management activities in product realization were not maintained.
Records of risk management activities in product realization were not adequately maintained.
Records of risk management activities in product realization were not adequately maintained.
Records of risk management activities in product realization were not adequately maintained.
Records of risk management activities in product realization were not adequately maintained.
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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