FDA 483 OBSERVATION · #351 OF 1,000 MOST-CITED
Defined areas of adequate size for operations
FDA cited this observation 59 times across 57 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 separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
The control systems necessary to prevent contamination or mix-ups are deficient.
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
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.