FDA 483 OBSERVATION · #535 OF 1,000 MOST-CITED
Listing and interpretation of CD tests performed
FDA cited this observation 35 times across 33 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 2.9× the rate of the average FDA-cited firm (24.2% vs 8.3%), across 33 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
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
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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