FDA 483 OBSERVATION · #390 OF 1,000 MOST-CITED
Second person sign off
FDA cited this observation 51 times across 50 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
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
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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