Violation Code: 118
FDA Violation
Charge Code: NOT LISTED
Violation Details
- Violation Code (ASC ID)
- 118
- Charge Code
- NOT LISTED
- Description
- It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
- Legal Section
- 502(o), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Convertors De Mexico | Juarez, MEXICO | 58185 |
| 2 | Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc, MEXICO | 1222 |
| 3 | Tinopal Surgical Corp. (Pvt) Ltd. | Sialkot, PAKISTAN | 491 |
| 4 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 360 |
| 5 | Warsaw Orthopedic, Inc. | Warsaw, UNITED STA | 329 |
| 6 | Medtronic Sofamor Danek USA, Inc | Memphis, UNITED STA | 285 |
| 7 | F.L. Medical S.R.L. | Padova, ITALY | 277 |
| 8 | NIPRO CORP. | Odate, JAPAN | 271 |
| 9 | P.T. Nipro Indonesia Jaya | Karawang, INDONESIA | 266 |
| 10 | Luxottica Spa | Milan, ITALY | 200 |
| 11 | Suzhou Armocon Technology Co.Ltd | Suzhou, CHINA | 186 |
| 12 | Cirpro De Delicias | Apartado Postal, MEXICO | 153 |
| 13 | Jr Beauty Enterprise Sdn Bhd | Kuala Lumpur, MALAYSIA | 150 |
| 14 | GlaxoSmithKline Panama S.A. | Panama, PANAMA | 148 |
| 15 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 145 |
| 16 | Smiths Healthcare Manufacturing SA de CV | Ciudad Apodaca, MEXICO | 140 |
| 17 | Miyuki Elex Co.,Ltd | Higashiosaka, JAPAN | 137 |
| 18 | Mian Shahid Corporation | Muzaffar Pur Sialkot, PAKISTAN | 134 |
| 19 | Nobel Biocare | The Netherlands, NETHERLAND | 134 |
| 20 | SALVA NEW SRL | Turin, ITALY | 129 |
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 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IY01 | NELSON NATURALS INCCANADA |
| 1/22/2026 | ONABOTULINUMTOXINA 58PCZ05 | Merz Pharma GmbH & Co., KGaAGERMANY |
| 1/22/2026 | FACIAL IMPLANT 79ODU | DENTOLINECOLOMBIA |
| 1/22/2026 | SODIUM CHLORIDE (REPLENISHER) 65RCK19 | FRESENIUS KABI BIDIPHAR JSCVIETNAM |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YCY99 | WWW.R3JUVEN8.ETAUSTRALIA |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YMY99 | LDI LAPUKE DRUG INCPHILIPPINE |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YRY99 | LDI LAPUKE DRUG INCPHILIPPINE |
| 1/22/2026 | COMPONENTS, WHEELCHAIR 89KNN | HL CORP SHENZHENCHINA |
| 1/22/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Merz North America, Inc.UNITED STA |
| 1/22/2026 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | |
| 1/22/2026 | MOUTHGUARD 76MQC | GLIDEWELL MEXICOMEXICO |
| 1/22/2026 | TITANIUM DIOXIDE (PROTECTANT) 65LBJ11 | COIZ Co., Ltd.SOUTH KORE |
| 1/22/2026 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBY99 | COSRX INCSOUTH KORE |
Related Violations
Other violations under the same legal section: 502(o), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 118?
118 is an FDA violation code that indicates: "It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).". This violation is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 118?
According to FDA Import Refusal data, there have been 133902 import refusals issued for violation code 118, affecting 29644 unique firms.
When was the most recent refusal for violation 118?
The most recent import refusal for violation 118 was on January 22, 2026.
What products are commonly refused for violation 118?
Products commonly refused under violation 118 include: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM., OVER-THE-COUNTER COVID-19 ANTIGEN TEST, DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS), ONABOTULINUMTOXINA, FACIAL IMPLANT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 118?
Violation code 118 is based on 502(o), 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.