FDA 483 OBSERVATION · #983 OF 1,000 MOST-CITED
Investigator records of relevant observations inadequate
FDA cited this observation 17 times across 17 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 for each subject concerning previous medical history, condition upon entering the investigation and condition during the course of the investigation are not all accurate, complete and current.
Records for each subject concerning previous medical history and condition during the course of the investigation are not all accurate and complete.
Records for each subject concerning previous medical history, condition upon entering the investigation, condition during the course of the investigation and all diagnostic test results are not all accurate, complete and current.
Records for each subject concerning condition during the course of the investigation are not all complete.
Records for each subject concerning previous medical history, condition upon entering the investigation and condition during the course of the investigation are not all accurate, complete and current.
Records for each subject concerning condition during the course of the investigation are not all accurate and complete.
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.