Violation Code: 286
FDA Violation
Charge Code: POISON PKG
Violation Details
- Violation Code (ASC ID)
- 286
- Charge Code
- POISON PKG
- Description
- The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.
- Legal Section
- 502(p), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | SHENYANG DELONG BR | Shenyang, CHINA | 3 |
| 2 | Choice Laboratories Limited | Ahmadabad, INDIA | 2 |
| 3 | Oku-Tan International Ltd. | Lagos, NIGERIA | 1 |
| 4 | Leung Kai Fook Medical Co Pte | Singapore, SINGAPORE | 1 |
| 5 | Brian Binsham | Calgary, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/5/2021 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDA99 | SHENYANG DELONG BRCHINA |
| 11/5/2021 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDA99 | SHENYANG DELONG BRCHINA |
| 11/5/2021 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDA99 | SHENYANG DELONG BRCHINA |
| 8/2/2004 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY04 | |
| 8/2/2004 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY04 | |
| 7/5/2002 | ASPIRIN (ANALGESIC) 60LIA05 | Brian BinshamCANADA |
| 5/8/2002 | ANTI-EMETIC/NAUSEANT N.E.C. 61TAR99 | Oku-Tan International Ltd.NIGERIA |
| 5/3/2002 | ANALGESIC, N.E.C. 60LBJ99 | Leung Kai Fook Medical Co PteSINGAPORE |
Frequently Asked Questions
What is FDA violation code 286?
286 is an FDA violation code that indicates: "The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.". This violation is based on 502(p), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 286?
According to FDA Import Refusal data, there have been 8 import refusals issued for violation code 286, affecting 5 unique firms.
When was the most recent refusal for violation 286?
The most recent import refusal for violation 286 was on November 5, 2021.
What products are commonly refused for violation 286?
Products commonly refused under violation 286 include: EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C., SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 286?
Violation code 286 is based on 502(p), 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.