FDA 483 OBSERVATION · #964 OF 1,000 MOST-CITED
Periodic equipment inspections
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
Periodic inspections of equipment were not conducted to ensure adherence to applicable maintenance schedules.
Periodic inspections of equipment conducted to ensure adherence to applicable maintenance schedules were not documented.
Periodic inspections of equipment were not conducted to ensure adherence to applicable maintenance schedules.
Periodic inspections of equipment were not conducted to ensure adherence to applicable maintenance schedules were not documented.
Periodic inspections of equipment were not conducted to ensure adherence to applicable maintenance schedules.
Periodic inspections of equipment conducted to ensure adherence to applicable maintenance schedules were not documented.
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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