Violation Code: 3871
FDA Violation
Charge Code: 708NODIREC
Violation Details
- Violation Code (ASC ID)
- 3871
- Charge Code
- 708NODIREC
- Description
- The article has been determined to lack adequate directions for use.
- Legal Section
- 502(f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Indena S.p.A. | Settala, ITALY | 1 |
| 2 | RIMOS SRL | Mirandola, ITALY | 1 |
| 3 | Zhuji Jianhe Paper Co., Ltd | Shaoxing, CHINA | 1 |
| 4 | UNITRADE | Business Bay Dub, UNITED ARA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/17/2024 | ANIMAL MEDICAL DEVICES, NEC 68ZYG99 | RIMOS SRLITALY |
| 3/4/2021 | RESERPINE (ANTI-HYPERTENSIVE) 62CCT51 | Indena S.p.A.ITALY |
| 1/20/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HBY05 | |
| 9/4/2020 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | UNITRADEUNITED ARA |
Related Violations
Other violations under the same legal section: 502(f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3871?
3871 is an FDA violation code that indicates: "The article has been determined to lack adequate directions for use.". This violation is based on 502(f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3871?
According to FDA Import Refusal data, there have been 4 import refusals issued for violation code 3871, affecting 4 unique firms.
When was the most recent refusal for violation 3871?
The most recent import refusal for violation 3871 was on May 17, 2024.
What products are commonly refused for violation 3871?
Products commonly refused under violation 3871 include: ANIMAL MEDICAL DEVICES, NEC, RESERPINE (ANTI-HYPERTENSIVE), 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 3871?
Violation code 3871 is based on 502(f)(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.