Violation Code: 2280
FDA Violation
Charge Code: DIRSEXMPT
Violation Details
- Violation Code (ASC ID)
- 2280
- Charge Code
- DIRSEXMPT
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
- Legal Section
- 502(f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Hebei Meiwei Chinese Medicinal Herbs Co., LTD | Anguo City, CHINA | 69 |
| 2 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 44 |
| 3 | PLATINA COSMETICOS LTDA | Uberaba, BRAZIL | 35 |
| 4 | Lelypharma BV | Lelystad, NETHERLAND | 29 |
| 5 | DREAM COSMETICS | Abigian, IVORY COAS | 25 |
| 6 | FUKUWARAKU COMPANY LTD | Osaka, JAPAN | 23 |
| 7 | GFR Pharma Ltd. | Coquitlam, CANADA | 20 |
| 8 | DCS EXPORT | Banbury, UNITED KIN | 20 |
| 9 | XIAMEN YUANJINCHEN TRADING CO,.LTD | Xiamen, CHINA | 19 |
| 10 | Biotest Medical Diagnostics Gmbh | Dreieich, GERMANY | 18 |
| 11 | Unilever Philippines, Inc. - Cavite Factory | Calabarzon, PHILIPPINE | 17 |
| 12 | PT Beiersdorf Indonesia | Malang, INDONESIA | 12 |
| 13 | Canadian Phytopharmaceuticals | Richmond, CANADA | 11 |
| 14 | Radiantly Alive | Bali, INDONESIA | 11 |
| 15 | Zhejiang Peptites Biotech Co.,Ltd. | Shaoxing, CHINA | 10 |
| 16 | Attote | Korhogo, IVORY COAS | 10 |
| 17 | HILTON HERBS LTD | Crewkerne, UNITED KIN | 9 |
| 18 | Sinerga S.p.A. | Gorla Maggiore, ITALY | 9 |
| 19 | Veritacor Manufacturing, LLC | Luling, UNITED STA | 9 |
| 20 | Beauty White Links | Batangas, PHILIPPINE | 9 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/30/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 12/16/2025 | ANTI-CONVULSANT, N.E.C. 61MIS99 | |
| 11/25/2025 | PEPTIDE N.E.C. 56FYY99 | BOLISE CO LIMITEDCHINA |
| 11/6/2025 | FENBENDAZOLE (ANTIPARASITIC) 60ZCY12 | UAB CANCHEMALITHUANIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
| 10/31/2025 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI02 | PT Beiersdorf IndonesiaINDONESIA |
Related Violations
Other violations under the same legal section: 502(f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 2280?
2280 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 within the meaning of Section 201(g) and it lacks adequate directions for use.". This violation is based on 502(f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2280?
According to FDA Import Refusal data, there have been 1322 import refusals issued for violation code 2280, affecting 567 unique firms.
When was the most recent refusal for violation 2280?
The most recent import refusal for violation 2280 was on December 30, 2025.
What products are commonly refused for violation 2280?
Products commonly refused under violation 2280 include: PEPTIDE N.E.C., ANTI-CONVULSANT, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2280?
Violation code 2280 is based on 502(f)(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.