FDA 483 OBSERVATION · #921 OF 1,000 MOST-CITED
Retest of approved components/containers/closures
FDA cited this observation 15 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
Approved drug product containers are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
Approved components, drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
Approved components and drug product containers are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods and exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
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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