FDA 483 OBSERVATION · #628 OF 1,000 MOST-CITED
Written procedures - establish; packaging & labeling
FDA cited this observation 28 times across 28 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 labeling operations and packaging operations.
You did not establish written procedures for labeling operations and packaging operations.
You did not establish written procedures for labeling operations and packaging operations.
You did not establish written procedures for labeling operations and packaging operations.
You did not establish written procedures for labeling operations.
You did not establish written procedures for labeling operations and packaging operations.
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.