FDA 483 OBSERVATION · #684 OF 1,000 MOST-CITED
Equipment suitability & capability
FDA cited this observation 25 times across 25 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
Certain test equipment is not capable of producing valid results.
Certain inspection, measuring and test equipment is not suitable for its intended purposes and capable of producing valid results.
Certain inspection, measuring and test equipment is not suitable for its intended purposes and capable of producing valid results.
Certain test equipment is not suitable for its intended purposes.
Certain inspection and measuring equipment is not suitable for its intended purposes and capable of producing valid results.
Certain inspection equipment is not suitable for its intended purposes.
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.