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 | 60 |
| 5 | Medtronic Inc | Mounds View, UNITED STA | 52 |
| 6 | Medtronic Sofamor Danek USA, Inc | Memphis, UNITED STA | 51 |
| 7 | Warsaw Orthopedic, Inc. | Warsaw, UNITED STA | 46 |
| 8 | Bodyjewellleryshop Ltd | Watford, UNITED KIN | 45 |
| 9 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 44 |
| 10 | E-FILLERS SA | Athens, GREECE | 42 |
| 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 |
|---|---|---|
| 12/23/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Medytox Inc.SOUTH KORE |
| 12/19/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 12/19/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 12/18/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | Vision Science Co., Ltd.SOUTH KORE |
| 12/18/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | DIMALASH AND DIMALENSUNITED ARA |
| 12/18/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | WellsPharmtech Co., LtdSOUTH KORE |
| 12/17/2025 | CASE, CONTACT LENS 86LRX | Seed Company, Ltd.JAPAN |
| 12/17/2025 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD | Westcomb OuterwearCANADA |
| 12/16/2025 | BANDAGE, ELASTIC 80FQM | MEDIWISE PTY LTDAUSTRALIA |
| 12/12/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 12/9/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | NAOKI IWASEJAPAN |
| 12/9/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | NAOKI IWASEJAPAN |
| 12/9/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | NAOKI IWASEJAPAN |
| 12/9/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | NAOKI IWASEJAPAN |
| 12/9/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | NAOKI IWASEJAPAN |
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 3814 import refusals issued for violation code 237, affecting 1648 unique firms.
When was the most recent refusal for violation 237?
The most recent import refusal for violation 237 was on December 23, 2025.
What products are commonly refused for violation 237?
Products commonly refused under violation 237 include: IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE, LENSES, SOFT CONTACT, DAILY WEAR. 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.