FDA 483 OBSERVATION · #1076 OF 1,932 MOST-CITED
Deviations--evaluation, cause, corrective action
FDA cited this observation 15 times across 14 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.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation, efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
Investigation of deviations related to core CGTP requirements did not include efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation, efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation, efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation and corrective action(s) to address the deviation and prevent recurrence.
Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation, efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
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. Open the 483 observation explorer →