FDA 483 OBSERVATION · #267 OF 1,000 MOST-CITED
Written records kept in individual logs
FDA cited this observation 83 times across 83 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
Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Written records of major equipment use are not included in individual equipment logs.
Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Written records of major equipment cleaning and use are not included in individual equipment logs.
Written records of major equipment cleaning and use are not included in individual equipment logs.
Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
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.