Violation Code: 2461
FDA Violation
Charge Code: UNSFDIETUS
Violation Details
- Violation Code (ASC ID)
- 2461
- Charge Code
- UNSFDIETUS
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
- Legal Section
- 402(f)(1)(D), 801(a)(3) Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Viral Corporation | Lodhika, INDIA | 16 |
| 2 | Peekay International Inc. | Maspeth, UNITED STA | 10 |
| 3 | J R SHAH | Gujarat., INDIA | 5 |
| 4 | KHYATI ADVISORY SERVICES LTD | Mumbai, INDIA | 3 |
| 5 | Zhuhai City Tonghui Pharmaceutical Co.,Ltd. | Zhuhai, CHINA | 2 |
| 6 | Anihui Helin Pharmaceutical Co., Ltd. | Bozhou, CHINA | 2 |
| 7 | CV SUMBER REJEKI | Semarang, INDONESIA | 2 |
| 8 | Fung Song Pharm Biotechnology Co., Ltd. | Tainan, TAIWAN | 2 |
| 9 | Irvan Januardi | Pontianakpontianak, INDONESIA | 2 |
| 10 | Kaiser Pharmaceutical Co. | Tainan City, TAIWAN | 2 |
| 11 | Min Tong Pharmaceutical Company | Taichung, TAIWAN | 2 |
| 12 | Sunsho Pharmaceutical Co., Ltd. | Fujinomiya, JAPAN | 1 |
| 13 | Guangxi Wuzhou Zhongsen Pharmaceutical Co., Ltd. | Wuzhou, CHINA | 1 |
| 14 | Guilin Fengrunlai Biotech Corp. | Guilin, CHINA | 1 |
| 15 | H.K. EXPORTS | Ahmedabad, INDIA | 1 |
| 16 | Iovate Health Sciences International Inc. | Oakville, CANADA | 1 |
| 17 | Tree Of Life Northeast, Inc. | North Bergen, UNITED STA | 1 |
| 18 | Jack Hua Co., Ltd | Bangkok, THAILAND | 1 |
| 19 | Jilin Provincial Jingjin Import & Export | Changchun, CHINA | 1 |
| 20 | Chong Kun Dang Healthcare FD Co.,Ltd | Chungju, SOUTH KORE | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/27/2024 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCA99 | |
| 9/10/2024 | BETEL NUT, SHELLED 23BGT14 | H.K. EXPORTSINDIA |
| 8/5/2024 | BETEL NUT (HERBAL AND BOTANICALS, NOT TEAS II) 54KBT11 | |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 7/18/2024 | BETEL NUT, SHELLED 23BGY14 | Peekay International Inc.UNITED STA |
| 5/16/2024 | BETEL NUT (HERBAL AND BOTANICAL TEAS II, CONTINUED) 54JCY11 | |
| 4/8/2024 | NUTS OR EDIBLE SEEDS NOT MENTIONED ELSEWHERE, N.E.C. 23YGT99 |
Frequently Asked Questions
What is FDA violation code 2461?
2461 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 dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.". This violation is based on 402(f)(1)(D), 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2461?
According to FDA Import Refusal data, there have been 70 import refusals issued for violation code 2461, affecting 33 unique firms.
When was the most recent refusal for violation 2461?
The most recent import refusal for violation 2461 was on December 27, 2024.
What products are commonly refused for violation 2461?
Products commonly refused under violation 2461 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C., BETEL NUT, SHELLED, BETEL NUT (HERBAL AND BOTANICALS, NOT TEAS II). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2461?
Violation code 2461 is based on 402(f)(1)(D), 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.