FDA 483 OBSERVATION · #881 OF 1,000 MOST-CITED
Complaint handling procedures not documented
FDA cited this observation 16 times across 16 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 for timely complaint handling have not been documented.
Procedures for timely complaint handling have not been adequately documented.
Procedures for timely complaint handling have not been adequately documented.
Procedures for timely complaint handling have not been adequately documented.
Procedures for timely complaint handling have not been adequately documented.
Procedures for timely complaint handling have not been adequately documented.
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.