FDA 483 OBSERVATION · #545 OF 1,932 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 grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.9× the rate of the average FDA-cited firm (7.3% vs 7.8%), 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. Open the 483 observation explorer →