Violation Code: 508
FDA Violation
Charge Code: NO 510(K)
Violation Details
- Violation Code (ASC ID)
- 508
- Charge Code
- NO 510(K)
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
- Legal Section
- 801(a)(3); 502(o) Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Smiths Healthcare Manufacturing S.A. de C.V. | Tijuana, MEXICO | 531 |
| 2 | Smiths Healthcare Manufacturing SA de CV | Ciudad Apodaca, MEXICO | 437 |
| 3 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 354 |
| 4 | Suzhou Armocon Technology Co.Ltd | Suzhou, CHINA | 204 |
| 5 | NIPRO CORP. | Odate, JAPAN | 167 |
| 6 | P.T. Nipro Indonesia Jaya | Karawang, INDONESIA | 119 |
| 7 | Funky Vision Ltd | Louth, UNITED KIN | 101 |
| 8 | Lensmam Co. Ltd | Gyeonggi-do, SOUTH KORE | 96 |
| 9 | Edwards Lifesciences | Bajos De Haina, DOMINICAN | 93 |
| 10 | EPPENDORF AG | Hamburg, GERMANY | 91 |
| 11 | E-M Medical Treatment And Electron (Suzhou) Co Ltd | Suzhou, CHINA | 90 |
| 12 | Tomey Corporation | Nagoya, JAPAN | 89 |
| 13 | Shanghai Neo-Medical Import & Export Co., Ltd. | Shanghai, CHINA | 88 |
| 14 | Miyuki Elex Co.,Ltd | Higashiosaka, JAPAN | 86 |
| 15 | F.L. Medical S.R.L. | Padova, ITALY | 84 |
| 16 | LYMA LIFE LTD | London, UNITED KIN | 75 |
| 17 | GEO Medical Co., Ltd. | Buk, SOUTH KORE | 71 |
| 18 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BRAZIL | 67 |
| 19 | Ge Healthcare Logistique France | Cedex, FRANCE | 67 |
| 20 | Nipro Medical Industries, Ltd. | Tatebayashi, JAPAN | 65 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. 83QKP | |
| 1/22/2026 | OVER-THE-COUNTER COVID-19 ANTIGEN TEST 83QYT | ALTRUANGERMANY |
| 1/22/2026 | FACIAL IMPLANT 79ODU | DENTOLINECOLOMBIA |
| 1/22/2026 | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) 74MWI | |
| 1/22/2026 | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) 74MWI | |
| 1/22/2026 | OXIMETER 73DQA | |
| 1/21/2026 | LENS, CONTACT (DISPOSABLE) 86MVN | DreamCon Co. Ltd.SOUTH KORE |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | |
| 1/21/2026 | DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES) 85HDW | |
| 1/21/2026 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | |
| 1/21/2026 | ACCESSORIES, CATHETER, G-U 78KNY | CREGANNA MEDICALSRCOSTA RICA |
| 1/21/2026 | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC 90IYN | BUTTERFLY NETWORKUNITED STA |
| 1/21/2026 | CATHETER ACCESS COVER, TAMPER-RESISTANT 80PZW | Baxter Productos Medicos, Ltda.COSTA RICA |
| 1/21/2026 | LENS, CONTACT (OTHER MATERIAL) - DAILY 86HQD |
Frequently Asked Questions
What is FDA violation code 508?
508 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 post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.". This violation is based on 801(a)(3); 502(o) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 508?
According to FDA Import Refusal data, there have been 21847 import refusals issued for violation code 508, affecting 8831 unique firms.
When was the most recent refusal for violation 508?
The most recent import refusal for violation 508 was on January 22, 2026.
What products are commonly refused for violation 508?
Products commonly refused under violation 508 include: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM., OVER-THE-COUNTER COVID-19 ANTIGEN TEST, FACIAL IMPLANT, MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 508?
Violation code 508 is based on 801(a)(3); 502(o) 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.