FDA 483 OBSERVATION · #716 OF 1,932 MOST-CITED

Statement re: certified testing lab

FDA cited this observation 29 times across 27 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 Transplantation29
BY FISCAL YEAR
FY20261
FY20255
FY20244
FY20236
FY20224
FY20212
FY20201
FY20192
FY20182
FY20162

How FDA worded it — real examples

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

Lucina Egg Bank · San Diego, California · Human Tissue for Transplantation · 2026-04-10

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

The Advanced IVF Institute: Charles E. Miller, M.D. & Associates · Naperville, Illinois · Human Tissue for Transplantation · 2025-04-25

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

Global Premier Fertility Orange County LLC · Newport Beach, California · Human Tissue for Transplantation · 2025-04-11

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

New Directions Fertility Center · Gilbert, Arizona · Human Tissue for Transplantation · 2025-04-02

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

InVia Fertility Specialists, PLLC · Hoffman Estates, Illinois · Human Tissue for Transplantation · 2025-02-05

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.

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

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →