Violation Code: 478
FDA Violation
Charge Code: TISSUE
Violation Details
- Violation Code (ASC ID)
- 478
- Charge Code
- TISSUE
- Description
- This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.
- Legal Section
- 361
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Tutogen Medical Gmbh | Erlangen, GERMANY | 3 |
| 2 | Euroscreen | Gosselies, BELGIUM | 1 |
| 3 | Plus Endo | Roi, SWITZERLAN | 1 |
| 4 | LifeNet Health | Virginia Beach, UNITED STA | 1 |
| 5 | Sabina Zilberman | Middlesex, UNITED KIN | 1 |
| 6 | HC Biologics LLC | Miami, UNITED STA | 1 |
| 7 | Hans Biomed Corporation | Yuseong District, SOUTH KORE | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/3/2025 | BONE 57JH03 | HC Biologics LLCUNITED STA |
| 12/18/2009 | BONE 57JY03 | LifeNet HealthUNITED STA |
| 8/10/2006 | SEMEN (SPERM) 57KY01 | Sabina ZilbermanUNITED KIN |
| 11/30/2005 | FASCIA (HUMAN MUSCULOSKELETAL TISSUES) 57JH01 | Tutogen Medical GmbhGERMANY |
| 11/30/2005 | FASCIA (HUMAN MUSCULOSKELETAL TISSUES) 57JH01 | Tutogen Medical GmbhGERMANY |
| 11/4/2005 | PERICARDIUM (HUMAN TISSUE, OTHER TISSUES) 57OJ02 | EuroscreenBELGIUM |
| 11/22/2004 | HUMAN TISSUE, N.E.C. 57PH99 | Plus EndoSWITZERLAN |
| 9/29/2003 | SKIN (HUMAN TISSUE, OTHER TISSUES) 57OH01 | Hans Biomed CorporationSOUTH KORE |
| 6/23/2003 | FASCIA (HUMAN MUSCULOSKELETAL TISSUES) 57JH01 | Tutogen Medical GmbhGERMANY |
Frequently Asked Questions
What is FDA violation code 478?
478 is an FDA violation code that indicates: "This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.". This violation is based on 361 of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 478?
According to FDA Import Refusal data, there have been 9 import refusals issued for violation code 478, affecting 7 unique firms.
When was the most recent refusal for violation 478?
The most recent import refusal for violation 478 was on November 3, 2025.
What products are commonly refused for violation 478?
Products commonly refused under violation 478 include: BONE, SEMEN (SPERM), FASCIA (HUMAN MUSCULOSKELETAL TISSUES). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 478?
Violation code 478 is based on 361 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.