FDA 483 OBSERVATION · #713 OF 1,000 MOST-CITED
Process Controls Monitoring Frequency
FDA cited this observation 23 times across 23 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
Your process controls monitoring frequency was not adequate.
Your process controls monitoring frequency was not adequate.
Your process controls monitoring frequency was not adequate.
Your process controls monitoring frequency was not adequate.
Your process controls monitoring frequency was not adequate.
Your process controls monitoring frequency was not adequate.
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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