Violation Code: 3902
FDA Violation
Charge Code: FALSEDRUG
Violation Details
- Violation Code (ASC ID)
- 3902
- Charge Code
- FALSEDRUG
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.
- Legal Section
- 502(a)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Lelypharma BV | Lelystad, NETHERLAND | 29 |
| 2 | XIAMEN YUANJINCHEN TRADING CO,.LTD | Xiamen, CHINA | 17 |
| 3 | Qingdao Biopeptek Co., Ltd. | Qingdao, CHINA | 4 |
| 4 | Ludovico Martelli spa | Fiesole, ITALY | 4 |
| 5 | Nouvelle Cosmetologie Kaera | Abidjan, IVORY COAS | 2 |
| 6 | Prestige Blending | Ormeau, AUSTRALIA | 2 |
| 7 | E. Chamorro Industrial, S.A. | Granada, NICARAGUA | 2 |
| 8 | HALEON | Saint-Laurent, CANADA | 1 |
| 9 | Koret S. A. de C. V. | San Marcos, EL SALVADO | 1 |
| 10 | Beijing HKKY Medical Tech. Co., Ltd. | Beijing, CHINA | 1 |
| 11 | Guangzhou Livepro Beauty Cosmetics Co., Ltd | Guangzhou, CHINA | 1 |
| 12 | Laavo Clean, S.A. de C.V. | Ciudad Apodaca, MEXICO | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/26/2025 | STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY06 | HALEONCANADA |
| 9/26/2025 | PEPTIDE N.E.C. 56FIY99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | AGONIST, N.E.C. 60OCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 | |
| 5/2/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCT99 |
Frequently Asked Questions
What is FDA violation code 3902?
3902 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.". This violation is based on 502(a)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3902?
According to FDA Import Refusal data, there have been 65 import refusals issued for violation code 3902, affecting 12 unique firms.
When was the most recent refusal for violation 3902?
The most recent import refusal for violation 3902 was on September 26, 2025.
What products are commonly refused for violation 3902?
Products commonly refused under violation 3902 include: STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC), PEPTIDE N.E.C., MISCELLANEOUS PATENT MEDICINES, ETC.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3902?
Violation code 3902 is based on 502(a)(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.