FDA 483 OBSERVATION · #542 OF 1,000 MOST-CITED
Name and personal info on accompanying records
FDA cited this observation 45 times across 41 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 1× the rate of the average FDA-cited firm (7.3% vs 7.7%), across 41 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 accompanying records for HCT/Ps included the donor's name and personal information that might identify the donor.
The accompanying records for HCT/Ps included the donor's name.
The accompanying records for HCT/Ps included the donor's name and personal information that might identify the donor.
The accompanying records for HCT/Ps included the donor's name.
The accompanying records for HCT/Ps included the donor's name and personal information that might identify the donor.
The accompanying records for HCT/Ps included personal information that might identify the donor.
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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