FDA 483 OBSERVATION · #418 OF 1,000 MOST-CITED
Written environmental monitoring plan
FDA cited this observation 47 times across 30 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
You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
You did not establish and implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
You did not implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
You did not establish and implement a written environmental monitoring plan designed to identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
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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