FDA 483 OBSERVATION · #728 OF 1,000 MOST-CITED
Measured, recorded
FDA cited this observation 27 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
A critical factor specified in the scheduled process was not measured and recorded on the processing record.
A critical factor specified in the scheduled process was not measured and recorded on the processing record.
A critical factor specified in the scheduled process was not measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factor was within the limits specified in the scheduled process.
A critical factor specified in the scheduled process was not measured and recorded on the processing record.
A critical factor specified in the scheduled process was not measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factor was within the limits specified in the scheduled process.
A critical factor specified in the scheduled process was not measured and recorded on the processing record.
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.