Violation Code: 483
FDA Violation
Charge Code: DRUG NAME
Violation Details
- Violation Code (ASC ID)
- 483
- Charge Code
- DRUG NAME
- Description
- The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
- Legal Section
- 502(e)(1); 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BRITISH VITATECH | Leicester, UNITED KIN | 23 |
| 2 | DCS EXPORT | Banbury, UNITED KIN | 20 |
| 3 | Vaidyaratnam Oushadhasala Pvt Ltd | Thrissur, INDIA | 17 |
| 4 | Homeolab USA Inc. | Montreal, CANADA | 16 |
| 5 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 16 |
| 6 | Dr Irena Eris S.A. | Piaseczno, POLAND | 14 |
| 7 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 13 |
| 8 | Splash Corporation | Valenzuela City, PHILIPPINE | 12 |
| 9 | Hsahnaz Herbals | New Delhi, INDIA | 11 |
| 10 | Bie-Dro C. Nuyken Kg | Bielefeld, GERMANY | 9 |
| 11 | ADI INDUSTRY CO LIMITED | Kowloon Bay, HONG KONG | 9 |
| 12 | Homeovitality Company | Preston, UNITED KIN | 9 |
| 13 | Cosbel S.A de C.V. | Ciudad De Mexico, MEXICO | 9 |
| 14 | Unilever Philippines, Inc. - Cavite Factory | Calabarzon, PHILIPPINE | 8 |
| 15 | Groupe Panther Sa | St Ouen, FRANCE | 8 |
| 16 | Tulsi Exports | New Delhi, INDIA | 8 |
| 17 | Dpc Limited | Kowloon, HONG KONG | 8 |
| 18 | J.D. Corporation | Masjid Bunder, INDIA | 7 |
| 19 | Dr. Juga Ltd | Budapest Ix, HUNGARY | 7 |
| 20 | AGRO IMPEX | Mumbai, INDIA | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/12/2026 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIZ99 | |
| 1/6/2026 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBY17 | Mondelez CanadaCANADA |
| 12/20/2025 | MENTHOL (ANTI-PRURITIC) 62MAJ08 | |
| 12/20/2025 | ENFLURANE (ANESTHETIC) 60QBJ09 | |
| 12/20/2025 | DIBUCAINE (ANESTHETIC) 60QAJ34 | |
| 12/20/2025 | HYDROCORTISONE (GLUCOCORTICOID) 64LAJ37 | |
| 12/20/2025 | LIDOCAINE HCL (ANESTHETIC) 60QBL40 | |
| 12/20/2025 | ALLANTOIN (PROTECTANT) 65LAJ02 | |
| 12/16/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | |
| 12/1/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDL99 | BIOHEAL OTTAWACANADA |
| 11/25/2025 | PEPTIDE N.E.C. 56FYY99 | BOLISE CO LIMITEDCHINA |
| 11/13/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | DUKSAN PURE CHEMICALS CO., LTD.SOUTH KORE |
| 11/10/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | Vnx TradeMALAYSIA |
| 10/3/2025 | STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY06 | HALEONCANADA |
| 10/3/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBU17 | Revlon Group Holdings, LLCUNITED STA |
Related Violations
Other violations under the same legal section: 502(e)(1); 801(a)(3); Misbranding
| Code | Charge Code | Cases |
|---|---|---|
| 3000 | N-RX INACT | 261 |
Frequently Asked Questions
What is FDA violation code 483?
483 is an FDA violation code that indicates: "The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.". This violation is based on 502(e)(1); 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 483?
According to FDA Import Refusal data, there have been 1332 import refusals issued for violation code 483, affecting 776 unique firms.
When was the most recent refusal for violation 483?
The most recent import refusal for violation 483 was on January 12, 2026.
What products are commonly refused for violation 483?
Products commonly refused under violation 483 include: MISCELLANEOUS PATENT MEDICINES, ETC., ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT), MENTHOL (ANTI-PRURITIC), ENFLURANE (ANESTHETIC), DIBUCAINE (ANESTHETIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 483?
Violation code 483 is based on 502(e)(1); 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.