FDA 483 OBSERVATION · #88 OF 1,000 MOST-CITED
Written procedures - product complaint
FDA cited this observation 253 times across 230 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
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish and follow written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
You did not establish written procedures for the requirements to review and investigate a product complaint.
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.