Violation Code: 3895
FDA Violation
Charge Code: NIOSH-EUA
Violation Details
- Violation Code (ASC ID)
- 3895
- Charge Code
- NIOSH-EUA
- Description
- The respirator is from a lot or shipment that failed testing and, pursuant to a condition of the applicable emergency use authorization (EUA), cannot be distributed.
- Legal Section
- Section 564(e), Conditions of Emergency Use Authorization
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | DONGGUAN HUAGANG COMMUNICATION TECHNOLOGY CO., LTD. | Dongguan, CHINA | 4 |
| 2 | GUANGZHOU BAOWEIKANG LABOR PROTE | Guangzhou, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/26/2021 | MASK, SURGICAL 80FXX | |
| 3/26/2021 | MASK, SURGICAL 80FXX | |
| 3/26/2021 | MASK, SURGICAL 80FXX | |
| 3/26/2021 | MASK, SURGICAL 80FXX | |
| 9/18/2020 | RESPIRATOR, N95, HOME USE 80NZJ |
Frequently Asked Questions
What is FDA violation code 3895?
3895 is an FDA violation code that indicates: "The respirator is from a lot or shipment that failed testing and, pursuant to a condition of the applicable emergency use authorization (EUA), cannot be distributed.". This violation is based on Section 564(e), Conditions of Emergency Use Authorization of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3895?
According to FDA Import Refusal data, there have been 5 import refusals issued for violation code 3895, affecting 2 unique firms.
When was the most recent refusal for violation 3895?
The most recent import refusal for violation 3895 was on March 26, 2021.
What products are commonly refused for violation 3895?
Products commonly refused under violation 3895 include: MASK, SURGICAL, RESPIRATOR, N95, HOME USE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3895?
Violation code 3895 is based on Section 564(e), Conditions of Emergency Use Authorization 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.