FDA 483 OBSERVATION · #793 OF 1,000 MOST-CITED
Cleanliness, ISO-classified areas
FDA cited this observation 24 times across 24 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
The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
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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