Violation Code: 3869
FDA Violation
Charge Code: 708LBLFIRM
Violation Details
- Violation Code (ASC ID)
- 3869
- Charge Code
- 708LBLFIRM
- Description
- The article has been determined to to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
- Legal Section
- 502(b)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Shandong Jincheng Bio-pharmaceutical Co., Ltd | Zibo, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/5/2021 | METHIONINE (ACIDIFIER) 60BDA20 |
Related Violations
Other violations under the same legal section: 502(b)(1), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 333 | LACKS FIRM | 2373 |
Frequently Asked Questions
What is FDA violation code 3869?
3869 is an FDA violation code that indicates: "The article has been determined to to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.". This violation is based on 502(b)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3869?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3869, affecting 1 unique firms.
When was the most recent refusal for violation 3869?
The most recent import refusal for violation 3869 was on January 5, 2021.
What products are commonly refused for violation 3869?
Products commonly refused under violation 3869 include: METHIONINE (ACIDIFIER). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3869?
Violation code 3869 is based on 502(b)(1), 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.