FDA 483 OBSERVATION · #534 OF 1,000 MOST-CITED
Procedures for all other requirements
FDA cited this observation 35 times across 34 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 2.1× the rate of the average FDA-cited firm (17.6% vs 8.3%), across 34 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
You did not establish and maintain procedures that address the accompanying records after the donor eligibility determination is complete of HCT/Ps.
You did not establish and maintain procedures that address the retention of records related to testing, screening, and determining of donor eligibility of HCT/Ps.
You did not establish and maintain procedures that address the accompanying records after the donor eligibility determination is complete, storage of product from ineligible donors and cases of use when the donor eligibility determination is not required or there is an exception for reproductive use of HCT/Ps.
You did not establish and maintain procedures that address the retention of records related to testing, screening, and determining of donor eligibility of HCT/Ps.
You did not establish and maintain procedures that address cases of use when the donor eligibility determination is not required or there is an exception for reproductive use of HCT/Ps.
You did not establish and maintain procedures that address storage of product from ineligible donors and limited use of product from ineligible donors of HCT/Ps.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
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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