Violation Code: 2120
FDA Violation
Charge Code: UNSFDIETSP
Violation Details
- Violation Code (ASC ID)
- 2120
- Charge Code
- UNSFDIETSP
- Description
- The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
- Legal Section
- 402(f)(1)(B), 801(a)(3) Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Amc Line Express | Bekasi, INDONESIA | 152 |
| 2 | AMC | Bekasi, INDONESIA | 94 |
| 3 | SMEET CREATION PTE LTD | Singapore, SINGAPORE | 81 |
| 4 | Kaiser Pharmaceutical Co. | Tainan City, TAIWAN | 49 |
| 5 | Pt Rifa Agung | Pontianak Kalbar, INDONESIA | 35 |
| 6 | CV RAF | Pontianak, INDONESIA | 31 |
| 7 | adi dharma putra | Pontianak, INDONESIA | 30 |
| 8 | Batuah Maan Cv | Pontianak, INDONESIA | 30 |
| 9 | Eddy | Pontianakpontianak, INDONESIA | 28 |
| 10 | Pt Hny Ekspres Indonesia | Bekasi, INDONESIA | 24 |
| 11 | CV AQSA | Kalimantan Barat, INDONESIA | 20 |
| 12 | RYAN ONARA ROSNADI | Cirebon, INDONESIA | 19 |
| 13 | Rudi Hartona | Pontianak, INDONESIA | 18 |
| 14 | Sheng Chang Pharmaceutical Co., Ltd | Taipei, TAIWAN | 16 |
| 15 | Hvn Global Services Pte Ltd | Singapore, SINGAPORE | 15 |
| 16 | TSANG FOOK KEE MEDICINE COMPANY | Sai Ying Pun, HONG KONG | 13 |
| 17 | Jp Russell Science Ltd | Nicosia, CYPRUS | 13 |
| 18 | Tan Alaindo Mantina | Pontianak, INDONESIA | 13 |
| 19 | Febri Tri Ramadhanni | Pontianakpontianak, INDONESIA | 13 |
| 20 | EGI ASTRIA | Jakarta Selatan, INDONESIA | 13 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/24/2025 | QUINOA SEED (EDIBLE SEED) 23KGH09 | |
| 1/8/2025 | HERBALS & BOTANICAL TEAS, N.E.C. 54EBY99 | CV. IHSAN JAYA LOGISTIKINDONESIA |
| 1/8/2025 | HERBALS & BOTANICAL TEAS, N.E.C. 54EBY99 | CV. IHSAN JAYA LOGISTIKINDONESIA |
| 1/8/2025 | HERBALS & BOTANICAL TEAS, N.E.C. 54EBY99 | CV. IHSAN JAYA LOGISTIKINDONESIA |
| 8/14/2024 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | PREDATOR NUTRITION ONLINE LTDUNITED KIN |
| 8/14/2024 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | PREDATOR NUTRITION ONLINE LTDUNITED KIN |
| 8/8/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KEY12 | |
| 8/8/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KEY12 | |
| 6/6/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KBT12 | PT. Aditama Sentosa IndonesiaINDONESIA |
| 5/16/2024 | BETEL NUT (HERBAL AND BOTANICALS, NOT TEAS II) 54KCY11 | |
| 4/10/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KBY12 | EVOLUTION CONSULTING CO., LTDTHAILAND |
| 4/8/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KAT12 | PT SAHABAT SUKSES KALIMANTAN BARATINDONESIA |
| 4/4/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KEY12 | BIG TREA B VNETHERLAND |
| 3/26/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KAT12 | PT SAHABAT SUKSES KALIMANTAN BARATINDONESIA |
| 3/26/2024 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KAT12 | PT SAHABAT SUKSES KALIMANTAN BARATINDONESIA |
Frequently Asked Questions
What is FDA violation code 2120?
2120 is an FDA violation code that indicates: "The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.". This violation is based on 402(f)(1)(B), 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2120?
According to FDA Import Refusal data, there have been 2221 import refusals issued for violation code 2120, affecting 775 unique firms.
When was the most recent refusal for violation 2120?
The most recent import refusal for violation 2120 was on June 24, 2025.
What products are commonly refused for violation 2120?
Products commonly refused under violation 2120 include: QUINOA SEED (EDIBLE SEED), HERBALS & BOTANICAL TEAS, N.E.C., DIETARY CONVENTIONAL FOODS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2120?
Violation code 2120 is based on 402(f)(1)(B), 801(a)(3) Adulteration 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.