Violation Code: 71
FDA Violation
Charge Code: NO LICENSE
Violation Details
- Violation Code (ASC ID)
- 71
- Charge Code
- NO LICENSE
- Description
- The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
- Legal Section
- 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Biotest Medical Diagnostics Gmbh | Dreieich, GERMANY | 59 |
| 2 | HAAL IZA | Istanbul, TURKEY | 28 |
| 3 | Mcewen Laboratories Limited | Reading, UNITED KIN | 28 |
| 4 | Allergan Pharmaceuticals Ireland | Westport, IRELAND | 16 |
| 5 | Changchun Kangda Industry Co. Ltd. | Changchun, CHINA | 11 |
| 6 | MDC PACKING SERVICE | Isleworth, UNITED KIN | 10 |
| 7 | Netherlands Bone Bank Foundation | Leiden, NETHERLAND | 10 |
| 8 | EUROIMMUN Medizinische Labordiagnostika AG | Lubeck, GERMANY | 9 |
| 9 | GlaxoSmithKline Biologicals SA | Rixensart, BELGIUM | 8 |
| 10 | JINING WONDER TRADING CO LTD | Jining, CHINA | 8 |
| 11 | INMUNOTEK SL | Madrid, SPAIN | 7 |
| 12 | Ipsen BioPharm Ltd | Wrexham, UNITED KIN | 7 |
| 13 | Crucell Holland Bv | Leiden, NETHERLAND | 6 |
| 14 | DiaMed GmbH | Cressier Fr, SWITZERLAN | 6 |
| 15 | National Institute For Biological Standards And Control | Potters Bar, UNITED KIN | 6 |
| 16 | Shire Biologics, Div. of Shire Biochem Inc. | Sainte-Foy, CANADA | 5 |
| 17 | George Eliava Institute | Tbilisi, GEORGIA | 5 |
| 18 | Allergan Sales, LLC | Irvine, UNITED STA | 5 |
| 19 | CSL Behring GmbH | Marburg, GERMANY | 4 |
| 20 | Bgli | Weesp, NETHERLAND | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | HORMONE N.E.C. 64RCS99 | |
| 9/4/2025 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDY99 | |
| 9/2/2025 | FECAL MICROBIOTA TRANSPLANTATION (FMT) 57HH47 | CENTRE FOR DIGETIVE DISEASESAUSTRALIA |
| 8/18/2025 | INFLUENZA VIRUS VACCINE 57CI02 | Seqirus Vaccines LimitedUNITED KIN |
| 8/18/2025 | INFLUENZA VIRUS VACCINE 57CI02 | Seqirus Vaccines LimitedUNITED KIN |
| 8/18/2025 | INFLUENZA VIRUS VACCINE 57CI02 | Seqirus Vaccines LimitedUNITED KIN |
| 8/4/2025 | PLASMA (HUMAN) 57DY32 | PPD ZAVENTEMBELGIUM |
| 6/25/2025 | IN-VITRO DIAG PRODUCTS, N.E.C. 57VY99 | CORPORACION PARA INVESTIGACIONESCOLOMBIA |
| 3/4/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCA99 | VICTORIA PHARMAWORSWITZERLAN |
| 2/20/2025 | REAGENT RED BLOOD CELLS 57VI02 | Galenica SaCHILE |
| 7/26/2024 | BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. 57YY99 | LABORAITIRES NICAR INCCANADA |
| 7/26/2024 | BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. 57YY99 | LABORAITIRES NICAR INCCANADA |
| 7/26/2024 | ALLERGENIC PRODUCTS, N.E.C. 57GY99 | ALLERGEN SERVILAB SLSPAIN |
| 7/18/2024 | BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. 57YY99 | LABORAITIRES NICAR INCCANADA |
| 7/12/2024 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LD99 | IEUL BIOSCIENCES INC.SOUTH KORE |
Frequently Asked Questions
What is FDA violation code 71?
71 is an FDA violation code that indicates: "The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use". This violation is based on 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 71?
According to FDA Import Refusal data, there have been 539 import refusals issued for violation code 71, affecting 257 unique firms.
When was the most recent refusal for violation 71?
The most recent import refusal for violation 71 was on December 23, 2025.
What products are commonly refused for violation 71?
Products commonly refused under violation 71 include: HORMONE N.E.C., EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C., FECAL MICROBIOTA TRANSPLANTATION (FMT), INFLUENZA VIRUS VACCINE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 71?
Violation code 71 is based on 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT 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.