FDA 483 OBSERVATION · #122 OF 1,000 MOST-CITED
Lack of quality control unit
FDA cited this observation 191 times across 180 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
There is no quality control unit.
There is no quality control unit.
There is no quality control unit.
There is no quality control unit.
There is no quality control unit.
There is no quality control unit.
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.