Violation Code: 2480
FDA Violation
Charge Code: RXPERSONAL
Violation Details
- Violation Code (ASC ID)
- 2480
- Charge Code
- RXPERSONAL
- Description
- The article appears to be a device which requires a prescription from your doctor.
- Legal Section
- 502(a), 502(f)(1), 801(a)(3), MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Johnson & Johnson Vision Care Ireland UC | Limerick, IRELAND | 107 |
| 2 | Coopervision Manufacturing, Ltd. | Southampton, UNITED KIN | 102 |
| 3 | Funky Vision Ltd | Louth, UNITED KIN | 89 |
| 4 | CooperVisision Manufacturing Puerto Rico LLC | Juana Diaz, UNITED STA | 63 |
| 5 | Q-Med AB | Uppsala, SWEDEN | 55 |
| 6 | CIBA VISION Johor Sdn. Bhd. | Gelang Patah, MALAYSIA | 55 |
| 7 | Allergan Industrie SAS | Pringy, FRANCE | 45 |
| 8 | ClearLab US Inc. | Suwanee, UNITED STA | 33 |
| 9 | BAUSCH HEALTH IRELAND | Waterford, IRELAND | 31 |
| 10 | CIBA Vision Asian Manufacturing and Logistics Pte. Ltd. | Singapore, SINGAPORE | 27 |
| 11 | Johnson & Johnson Vision Care, Inc. | Jacksonville, UNITED STA | 27 |
| 12 | Black Banana Internet | Liskeardliskeard, UNITED KIN | 25 |
| 13 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 25 |
| 14 | Alcon Research LLC | Duluth, UNITED STA | 22 |
| 15 | Bausch & Lomb Incorporated | Rochester, UNITED STA | 21 |
| 16 | Ciba Vision GmbH | Groswallstadt, GERMANY | 21 |
| 17 | GEO Medical Co., Ltd. | Buk, SOUTH KORE | 19 |
| 18 | Pt Ciba Vision Batam | Batam Island, INDONESIA | 19 |
| 19 | Prollenium Medical Technologies Inc. | Aurora, CANADA | 16 |
| 20 | CooperVision CL KFT | Gyal, HUNGARY | 14 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/14/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Allergan Industrie SASFRANCE |
| 11/14/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | GALDERMA S.ASWITZERLAN |
| 11/14/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | GALDERMA S.ASWITZERLAN |
| 7/11/2025 | IMPLANT, ENDOSSEOUS 76DZE | |
| 7/11/2025 | IMPLANT, ENDOSSEOUS 76DZE | |
| 7/3/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | BIGFA JOINT STOCK COMPANYVIETNAM |
| 6/30/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | Interojo Inc.SOUTH KORE |
| 6/16/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 6/16/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 6/16/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 6/16/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Q-Med ABSWEDEN |
| 5/28/2025 | WIRE, GUIDE, CATHETER 74DQX | Boston Scientific CorporationUNITED STA |
| 5/28/2025 | WIRE, GUIDE, CATHETER 74DQX | Boston Scientific CorporationUNITED STA |
| 5/28/2025 | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE 74LOX | Boston Scientific CorporationUNITED STA |
| 5/28/2025 | SYRINGE, BALLOON INFLATION 74MAV | Boston Scientific CorporationUNITED STA |
Frequently Asked Questions
What is FDA violation code 2480?
2480 is an FDA violation code that indicates: "The article appears to be a device which requires a prescription from your doctor.". This violation is based on 502(a), 502(f)(1), 801(a)(3), MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2480?
According to FDA Import Refusal data, there have been 1315 import refusals issued for violation code 2480, affecting 355 unique firms.
When was the most recent refusal for violation 2480?
The most recent import refusal for violation 2480 was on November 14, 2025.
What products are commonly refused for violation 2480?
Products commonly refused under violation 2480 include: IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE, IMPLANT, ENDOSSEOUS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2480?
Violation code 2480 is based on 502(a), 502(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.