FDA 483 OBSERVATION · #917 OF 1,000 MOST-CITED
Written procedures lacking for use of pesticides etc.
FDA cited this observation 15 times across 15 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
Written procedures are lacking for the use of designed to prevent the contamination of.
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment.
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of components, drug product containers, closures and packaging, labeling materials.
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment.
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment, components, drug product containers, closures and drug products.
Written procedures are lacking for the use of rodenticides, insecticides, fungicides and cleaning and sanitizing agents designed to prevent the contamination of equipment, components and drug products.
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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