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 | 359 |
| 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 |
|---|---|---|
| 12/31/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | OLIVE INTERNATIONAL INCSOUTH KORE |
| 12/31/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBY17 | |
| 12/30/2025 | MICROSCOPE, SPECULAR 86NQE | Konan Medical Inc.JAPAN |
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/30/2025 | ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) 66PBJ18 | DONGHWA PHARMACEUTICALSOUTH KORE |
| 12/30/2025 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YAY99 | |
| 12/30/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIY99 | |
| 12/29/2025 | ANTIFUNGAL N.E.C. 56GAC99 | |
| 12/29/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | PEGAVISION CORPORATIONTAIWAN |
| 12/29/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | EISHO OPTICAL COJAPAN |
| 12/29/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | Interojo Inc.SOUTH KORE |
| 12/29/2025 | TENOFOVIR DISOPROXIL FUMERATE 62VDA15 | POSTNET - BRAAMFONTEINUNITED ARA |
| 12/29/2025 | BANDAGE, ELASTIC 80FQM | SED MERCIFRANCE |
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 133692 import refusals issued for violation code 118, affecting 29548 unique firms.
When was the most recent refusal for violation 118?
The most recent import refusal for violation 118 was on December 31, 2025.
What products are commonly refused for violation 118?
Products commonly refused under violation 118 include: IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE, ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT), MICROSCOPE, SPECULAR, PEPTIDE N.E.C.. 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.