FDA 483 OBSERVATION · #975 OF 1,000 MOST-CITED
Date and time of activity
FDA cited this observation 14 times across 13 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
All your required records do not include the date and time of the activity that the records reflect.
All your required records do not include the time of the activity that the records reflect.
All your required records do not include the time of the activity that the records reflect.
All your required records do not include the time of the activity that the records reflect.
All your required records do not include the time of the activity that the records reflect.
All your required records do not include the time of the activity that the records reflect.
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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