Violation Code: 84
FDA Violation
Charge Code: RX DEVICE
Violation Details
- Violation Code (ASC ID)
- 84
- Charge Code
- RX DEVICE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
- Legal Section
- 502(a),(f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | SOLOTICA DISTRIBUIDORA DE | Sao Paulo, BRAZIL | 60 |
| 2 | Q-Med AB | Uppsala, SWEDEN | 48 |
| 3 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 39 |
| 4 | Allergan Industrie SAS | Pringy, FRANCE | 33 |
| 5 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BRAZIL | 26 |
| 6 | TECNO INSTRUMENTS (PVT.) LTD. | Sialkot, PAKISTAN | 22 |
| 7 | Interojo Inc. | Pyeongtaek City, SOUTH KORE | 17 |
| 8 | Prollenium Medical Technologies Inc. | Aurora, CANADA | 15 |
| 9 | G & G Contact Lens Co. | Daegu, SOUTH KORE | 14 |
| 10 | Synthetek Industries Pty Ltd | Highett, AUSTRALIA | 10 |
| 11 | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD | Shenzhnsh, CHINA | 10 |
| 12 | Body Clock Health Care Ltd | London, UNITED KIN | 7 |
| 13 | GEO Medical Co., Ltd. | Buk, SOUTH KORE | 7 |
| 14 | LENS COM.DE ARTIGOS OPTICOS LTDA | Curitiba, BRAZIL | 7 |
| 15 | Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou, CHINA | 6 |
| 16 | Johnson & Johnson Vision Care, Inc. | Jacksonville, UNITED STA | 6 |
| 17 | UNIQSO HOLDINGS SDN BHD | Hulu Langat, MALAYSIA | 6 |
| 18 | SERP Societe Etudes Recherches Produits | Castelsarrasin, FRANCE | 5 |
| 19 | Lensmam Co. Ltd | Gyeonggi-do, SOUTH KORE | 5 |
| 20 | Multipack | Guerrero, MEXICO | 5 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/14/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | PEGAVISION CORPORATIONTAIWAN |
| 12/12/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | MIN JU KIMSOUTH KORE |
| 12/12/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | MIN JU KIMSOUTH KORE |
| 12/8/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Laboratoires VivacyFRANCE |
| 12/1/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | MIN JU KIMSOUTH KORE |
| 11/21/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 11/21/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Forever 18 InternationalSOUTH KORE |
| 11/20/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 11/14/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | |
| 11/10/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | 21st Century OpticsUNITED STA |
| 11/10/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 10/22/2025 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | PEGAVISION CORPORATIONTAIWAN |
| 10/22/2025 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | PEGAVISION CORPORATIONTAIWAN |
| 10/22/2025 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | PEGAVISION CORPORATIONTAIWAN |
| 10/22/2025 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | PEGAVISION CORPORATIONTAIWAN |
Frequently Asked Questions
What is FDA violation code 84?
84 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.". This violation is based on 502(a),(f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 84?
According to FDA Import Refusal data, there have been 876 import refusals issued for violation code 84, affecting 442 unique firms.
When was the most recent refusal for violation 84?
The most recent import refusal for violation 84 was on December 14, 2025.
What products are commonly refused for violation 84?
Products commonly refused under violation 84 include: LENS, CONTACT (DISPOSABLE), IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 84?
Violation code 84 is based on 502(a),(f)(1), 801(a)(3); MISBRANDING 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.