FDA 483 OBSERVATION · #760 OF 1,000 MOST-CITED
Establishment and Implementation of Corrective Action Procedures
FDA cited this observation 21 times across 20 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
You did not implement appropriate written corrective action procedures for preventive controls.
You did not establish appropriate written corrective action procedures for preventive controls.
You did not implement appropriate written corrective action procedures for preventive controls.
You did not establish and implement appropriate written corrective action procedures for preventive controls.
You did not implement appropriate written corrective action procedures for preventive controls.
You did not implement appropriate written corrective action procedures for preventive controls.
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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