FDA 483 OBSERVATION · #17 OF 1,000 MOST-CITED
Scientifically sound laboratory controls
FDA cited this observation 857 times across 735 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4.6× the rate of the average FDA-cited firm (35.4% vs 7.7%), across 735 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
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.
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