FDA 483 OBSERVATION · #847 OF 1,000 MOST-CITED
Status of Each Lot Identified
FDA cited this observation 22 times across 22 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
Each lot of components and closures was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
Each lot of components and drug product containers was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
Each lot of drug product containers and closures was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
Each lot of drug product containers was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
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.