FDA 483 OBSERVATION · #955 OF 1,000 MOST-CITED
Failure to comply with REMS Implementation System
FDA cited this observation 14 times across 13 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
An application holder did not comply with the audit plan and schedule described in the REMS, as required by your approved REMS Implementation System.
An application holder did not maintain the drug distribution and dispensing records to ensure restricted distribution, as required by your approved REMS Implementation System.
An application holder did not comply with the audit plan and schedule described in the REMS and maintain the drug distribution and dispensing records to ensure restricted distribution, as required by your approved REMS Implementation System.
An application holder did not comply with the audit plan and schedule described in the REMS, as required by your approved REMS Implementation System.
An application holder did not maintain the drug distribution and dispensing records to ensure restricted distribution, as required by your approved REMS Implementation System.
An application holder did not comply with the audit plan and schedule described in the REMS and maintain the drug distribution and dispensing records to ensure restricted distribution, as required by your approved REMS Implementation System.
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.