FDA 483 OBSERVATION · #884 OF 1,000 MOST-CITED
Raw material control - Inspection
FDA cited this observation 16 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
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
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.