FDA 483 OBSERVATION · #481 OF 1,000 MOST-CITED
Specimen collections not timely
FDA cited this observation 50 times across 48 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 2.2× the rate of the average FDA-cited firm (16.7% vs 7.7%), across 48 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
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.
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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