FDA 483 OBSERVATION · #94 OF 1,000 MOST-CITED
Prevention of contamination
FDA cited this observation 235 times across 195 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
Failure to maintain servicing area equipment in such a manner as to prevent contamination of drinking water.
Failure to maintain and operate servicing area piping systems, hydrants and hoses in such a manner as to prevent contamination of drinking and culinary water.
Failure to maintain servicing area equipment in such a manner as to prevent contamination of water.
Failure to maintain servicing area hoses and equipment in such a manner as to prevent contamination of water.
Failure to maintain and operate servicing area piping systems and equipment in such a manner as to prevent contamination of drinking water.
Failure to design, construct, maintain and operate servicing area piping systems, taps, faucets and hoses in such a manner as to prevent contamination of drinking and culinary water.
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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