Violation Code: 237
FDA Violation
Charge Code: NO PMA
Violation Details
- Violation Code (ASC ID)
- 237
- Charge Code
- NO PMA
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
- Legal Section
- 501(f)(1)(B), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Q-Med AB | Uppsala, SWEDEN | 109 |
| 2 | Admedes GmbH | Pforzheim, GERMANY | 104 |
| 3 | Medtronic Puerto Rico Operations Co. | Humacao, UNITED STA | 69 |
| 4 | Allergan Industrie SAS | Pringy, FRANCE | 61 |
| 5 | Medtronic Inc | Mounds View, UNITED STA | 52 |
| 6 | Medtronic Sofamor Danek USA, Inc | Memphis, UNITED STA | 51 |
| 7 | E-FILLERS SA | Athens, GREECE | 49 |
| 8 | Warsaw Orthopedic, Inc. | Warsaw, UNITED STA | 46 |
| 9 | Bodyjewellleryshop Ltd | Watford, UNITED KIN | 45 |
| 10 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 44 |
| 11 | Edwards Lifesciences | Bajos De Haina, DOMINICAN | 39 |
| 12 | Danamedic Aps | Kgs. Lyngby, DENMARK | 39 |
| 13 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 34 |
| 14 | Tae-Chang Industrial Co., Ltd. | Gumi, SOUTH KORE | 32 |
| 15 | Ultramax Products Ltd | Wakefield, UNITED KIN | 32 |
| 16 | Micro Therapeutics, Inc. | Irvine, UNITED STA | 31 |
| 17 | X4 Labs Inc. | Montreal, CANADA | 29 |
| 18 | Cs Innovation Pte | Sin, SINGAPORE | 25 |
| 19 | Mystim Gmbh | Mombris, GERMANY | 23 |
| 20 | Interojo Inc. | Pyeongtaek City, SOUTH KORE | 22 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | LENS, INTRAOCULAR 86HQL | EXCELLENT HI CAREINDIA |
| 1/21/2026 | LENS, CONTACT, FOR READING DISCOMFORT 86NIC | RESHIP.COMUNITED KIN |
| 1/21/2026 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | VASYL KUTSPORTUGAL |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | METHODOLOGYSOUTH KORE |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | AbbVie Inc.UNITED STA |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Across Co., LtdSOUTH KORE |
| 1/20/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Exocobio, Inc.SOUTH KORE |
| 1/20/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | BIOPLUS Co., LTDSOUTH KORE |
| 1/20/2026 | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53EL99 | E-FILLERS SAGREECE |
| 1/20/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | E-FILLERS SAGREECE |
| 1/20/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | E-FILLERS SAGREECE |
| 1/20/2026 | EYELASH CLEANSERS (EYE MAKEUP PREPARATIONS) 53CL15 | E-FILLERS SAGREECE |
| 1/20/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | AllerganUNITED STA |
| 1/12/2026 | COLLAGEN (COSMETIC RAW MATERIAL) 53PD02 |
Frequently Asked Questions
What is FDA violation code 237?
237 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).". This violation is based on 501(f)(1)(B), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 237?
According to FDA Import Refusal data, there have been 3842 import refusals issued for violation code 237, affecting 1657 unique firms.
When was the most recent refusal for violation 237?
The most recent import refusal for violation 237 was on January 22, 2026.
What products are commonly refused for violation 237?
Products commonly refused under violation 237 include: LENS, INTRAOCULAR, LENS, CONTACT, FOR READING DISCOMFORT, LENS, CONTACT (OTHER MATERIAL) - DAILY, 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 237?
Violation code 237 is based on 501(f)(1)(B), 801(a)(3); ADULTERATION 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.