FDA 483 OBSERVATION · #549 OF 1,932 MOST-CITED

Procedures for all other requirements

FDA cited this observation 45 times across 42 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.

BY PROGRAM AREA
Human Tissue for Transplantation45
BY FISCAL YEAR
FY20261
FY20251
FY20242
FY20231
FY20221
FY20211
FY201914
FY201811
FY20175
FY20168

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.8× the rate of the average FDA-cited firm (14.3% vs 7.8%), across 42 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.

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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.

University of Cincinnati Center For Reproductive Health · West Chester, Ohio · Human Tissue for Transplantation · 2026-02-26

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.

Cryobank America LLC · Arlington, Texas · Human Tissue for Transplantation · 2025-01-13

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.

The New York Fertility Center · Flushing, New York · Human Tissue for Transplantation · 2024-09-18

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.

E2P4 Labs · Plano, Texas · Human Tissue for Transplantation · 2024-09-17

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.

Florida Fertility Institute, P.A. · Clearwater, Florida · Human Tissue for Transplantation · 2023-02-02

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.

The New York Fertility Center · Flushing, New York · Human Tissue for Transplantation · 2022-09-23

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.

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