FDA 483 OBSERVATION · #211 OF 1,000 MOST-CITED
Identity Testing of Each Component
FDA cited this observation 111 times across 105 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
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
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.