FDA 483 OBSERVATION · #147 OF 1,000 MOST-CITED
Procedures for non-sterile drug products
FDA cited this observation 160 times across 151 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 designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not 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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.