FDA 483 OBSERVATION · #468 OF 1,000 MOST-CITED
Name and personal info on accompanying records
FDA cited this observation 41 times across 38 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.
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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