Violation Code: 3899
FDA Violation
Charge Code: NONRX505G
Violation Details
- Violation Code (ASC ID)
- 3899
- Charge Code
- NONRX505G
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of section 502(ee) of the FD&C Act, under which a drug is deemed to be misbranded if it is a nonprescription drug that is subject to section 505G of the FD&C Act but does not comply with the requirements for marketing under said section 505G and is not the subject of an application approved under section 505 of the FD&C Act.
- Legal Section
- 801(a)(3), 502(ee); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Laavo Clean, S.A. de C.V. | Ciudad Apodaca, MEXICO | 3 |
| 2 | HINDUSTAN HERBAL COSMETICS | Noida, INDIA | 2 |
| 3 | Zhejiang Qirun Daily Necessities Co., Ltd | Wenzhou, CHINA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 10/8/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAY05 | |
| 10/8/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAY05 | |
| 3/23/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 3/23/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 |
Frequently Asked Questions
What is FDA violation code 3899?
3899 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of section 502(ee) of the FD&C Act, under which a drug is deemed to be misbranded if it is a nonprescription drug that is subject to section 505G of the FD&C Act but does not comply with the requirements for marketing under said section 505G and is not the subject of an application approved under section 505 of the FD&C Act.". This violation is based on 801(a)(3), 502(ee); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3899?
According to FDA Import Refusal data, there have been 7 import refusals issued for violation code 3899, affecting 3 unique firms.
When was the most recent refusal for violation 3899?
The most recent import refusal for violation 3899 was on December 15, 2022.
What products are commonly refused for violation 3899?
Products commonly refused under violation 3899 include: ANTI-MICROBIAL N.E.C., ETHYL ALCOHOL (ANTI-MICROBIAL). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3899?
Violation code 3899 is based on 801(a)(3), 502(ee); 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.