FDA 483 OBSERVATION · #379 OF 1,000 MOST-CITED
Contamination control, Lack of or inadequate procedures
FDA cited this observation 52 times across 49 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
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been established.
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
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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