FDA 483 OBSERVATION · #417 OF 1,000 MOST-CITED
Precautions against contamination--micro, foreign substances
FDA cited this observation 48 times across 48 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 take necessary precautions to protect against contamination of food contact surfaces with microorganisms.
Failure to take necessary precautions to protect against contamination of food with microorganisms and foreign substances.
Failure to take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with microorganisms and foreign substances.
Failure to take necessary precautions to protect against contamination of food with microorganisms.
Failure to take necessary precautions to protect against contamination of food with microorganisms.
Failure to take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with microorganisms and foreign substances.
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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.