Violation Code: 3872
FDA Violation
Charge Code: 708LISTING
Violation Details
- Violation Code (ASC ID)
- 3872
- Charge Code
- 708LISTING
- Description
- It has been determined the drug is not included in a list required by Section 510(j).
- Legal Section
- 502(o), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | EC LABS SA | Cordoba, ARGENTINA | 2 |
| 2 | Wenzhou Shengkai Technology Industry Co., Ltd. | Wenzhou, CHINA | 2 |
| 3 | Pharmascience Inc. | La Prairie, CANADA | 1 |
| 4 | SANDOZ CANADA INC | Boucherville, CANADA | 1 |
| 5 | APOTEX INC | North York, CANADA | 1 |
| 6 | SIGMA INK S DE RL DE CV | Tijuana, MEXICO | 1 |
| 7 | KUSHAL AYURVEDIC PHARMACY | Urmi, INDIA | 1 |
| 8 | LAVER BEAUTY CO LTD | Shijiazhuang, CHINA | 1 |
| 9 | Alcon Research LLC | Fort Worth, UNITED STA | 1 |
| 10 | TEVA CANADA | Candiac, CANADA | 1 |
| 11 | Delpharm Boucherville Canada, Inc. | Boucherville, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/30/2024 | HYDROXYPROPYL CELLULOSE (PROTECTANT) 65LBY16 | Alcon Research LLCUNITED STA |
| 11/24/2023 | PANTOPRAZOLE SODIUM 62TDC07 | |
| 11/24/2023 | ROSUVASTATIN CALCIUM 61JDB16 | TEVA CANADACANADA |
| 11/24/2023 | METFORMIN HCL (ANTI-DIABETIC) 61PDB55 | Pharmascience Inc.CANADA |
| 11/24/2023 | BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) 62ODB18 | SANDOZ CANADA INCCANADA |
| 11/24/2023 | RAMIPRIL (ANTI-HYPERTENSIVE - PART II) 62ODY05 | APOTEX INCCANADA |
| 5/19/2023 | MENTHOL (ANTI-PRURITIC) 62MPJ08 | EC LABS SAARGENTINA |
| 5/19/2023 | ARNICA (HERBAL & BOTANICALS, NOT TEAS) 54FNJ32 | EC LABS SAARGENTINA |
| 3/17/2023 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBA99 | |
| 2/9/2023 | BOTOX 65QDY02 | LAVER BEAUTY CO LTDCHINA |
| 2/16/2022 | ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) 62FAL23 | |
| 2/16/2022 | ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) 62FAL23 | |
| 5/4/2020 | DISINFECTANT N.E.C. 64ACK99 | SIGMA INK S DE RL DE CVMEXICO |
Related Violations
Other violations under the same legal section: 502(o), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3872?
3872 is an FDA violation code that indicates: "It has been determined the drug is not included in a list required by Section 510(j).". This violation is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3872?
According to FDA Import Refusal data, there have been 13 import refusals issued for violation code 3872, affecting 11 unique firms.
When was the most recent refusal for violation 3872?
The most recent import refusal for violation 3872 was on August 30, 2024.
What products are commonly refused for violation 3872?
Products commonly refused under violation 3872 include: HYDROXYPROPYL CELLULOSE (PROTECTANT), PANTOPRAZOLE SODIUM, ROSUVASTATIN CALCIUM, METFORMIN HCL (ANTI-DIABETIC), BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3872?
Violation code 3872 is based on 502(o), 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.