FDA 483 OBSERVATION · #823 OF 1,000 MOST-CITED
Identification of Person Performing Review of Lab Records
FDA cited this observation 18 times across 18 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 are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.
Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.
Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.
Laboratory records are deficient in that they do not include the initials of the second person reviewing the record for accuracy.
Laboratory records are deficient in that they do not include the signature of the second person reviewing the record for accuracy.
Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record 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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