Violation Code: 3887
FDA Violation
Charge Code: ADDDRUGBIO
Violation Details
- Violation Code (ASC ID)
- 3887
- Charge Code
- ADDDRUGBIO
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.
- Legal Section
- 801(a)(3);301(ll); PROHIBITED ACT
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | CBDFX | Chatsworth, UNITED STA | 4 |
| 2 | PATANJALI AYURVED LIMITED | Haridwar, INDIA | 3 |
| 3 | AMIDZI NUTS AND SEEDS | Nairobi, KENYA | 2 |
| 4 | MD'E GUM SRL | Castenuovo Vomano, ITALY | 2 |
| 5 | Geo Medicore Limited | Accra-Ghana, GHANA | 2 |
| 6 | DRS SECRET WORLDWIDE MANUFACTURI | Pulau Pinang, MALAYSIA | 1 |
| 7 | HEGO FULFILMENT | Weert, NETHERLAND | 1 |
| 8 | societatea comerciala TAINET, SRL | Comrat, MOLDOVA | 1 |
| 9 | ZUTAN FOODS | Nairobi, KENYA | 1 |
| 10 | SK MART TRADING | Kuala Kelawang, MALAYSIA | 1 |
| 11 | Shalina Laboratories Limited | Mumbai, INDIA | 1 |
| 12 | FUTURE360 | Tallinn, ESTONIA | 1 |
| 13 | SILVER STAR RESOURCES CO., INC. | Quezon City, PHILIPPINE | 1 |
| 14 | Dru Era (Pvt) Ltd | Dehiwala, SRI LANKA | 1 |
| 15 | Indaco S.p.A. | Caivano, ITALY | 1 |
| 16 | JIANGMEN CHUANGKEQI FOOD TECH | Guangdong, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/20/2026 | SYRUPS AND MOLASSES, N.E.C. 36BCT99 | |
| 10/22/2025 | CINNAMON, CASSIA, GROUND, CRACKED (SPICE) 28BYY13 | Dru Era (Pvt) LtdSRI LANKA |
| 7/31/2025 | ENERGY DRINK CAFFEINE-FREE, NONCARBONATED, N.E.C. 29IYY99 | FUTURE360ESTONIA |
| 7/3/2025 | BARLEY, WHOLE GRAIN 02AYT02 | SILVER STAR RESOURCES CO., INC.PHILIPPINE |
| 6/11/2025 | HONEY, N.E.C. 36CYT99 | SK MART TRADINGMALAYSIA |
| 11/13/2024 | OTHER FORMULA PRODUCTS FOR SAMPLE TESTING (NOT FOR SALE), N.E.C. 40RYT99 | HEGO FULFILMENTNETHERLAND |
| 5/21/2024 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IG01 | |
| 5/21/2024 | LEAF & STEM VEGETABLES, WITH SAUCE, N.E.C. 24VCT99 | |
| 5/21/2024 | LEAF & STEM VEGETABLES, WITH SAUCE, N.E.C. 24VCT99 | |
| 4/29/2024 | OLIVE OIL WITH OTHER VEGETABLE OILS, REFINED 26DYY01 | |
| 4/29/2024 | MIXED NUTS, IN SHELL, N.E.C. 23GYY99 | |
| 4/29/2024 | CANDY WITHOUT CHOCOLATE N.E.C. 33YYY99 | ZUTAN FOODSKENYA |
| 1/6/2022 | CYPROHEPTADINE HCL (ANTI-HISTAMINIC) 61XBY14 | Geo Medicore LimitedGHANA |
| 4/14/2021 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBY99 | |
| 12/15/2020 | NICOTINE DELIVERY SYSTEM 66BCY44 | Indaco S.p.A.ITALY |
Related Violations
Other violations under the same legal section: 801(a)(3);301(ll); PROHIBITED ACT
| Code | Charge Code | Cases |
|---|---|---|
| 3884 | ADDDRUGBIO | 0 |
Frequently Asked Questions
What is FDA violation code 3887?
3887 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.". This violation is based on 801(a)(3);301(ll); PROHIBITED ACT of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3887?
According to FDA Import Refusal data, there have been 24 import refusals issued for violation code 3887, affecting 16 unique firms.
When was the most recent refusal for violation 3887?
The most recent import refusal for violation 3887 was on January 20, 2026.
What products are commonly refused for violation 3887?
Products commonly refused under violation 3887 include: SYRUPS AND MOLASSES, N.E.C., CINNAMON, CASSIA, GROUND, CRACKED (SPICE), ENERGY DRINK CAFFEINE-FREE, NONCARBONATED, N.E.C., BARLEY, WHOLE GRAIN, HONEY, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3887?
Violation code 3887 is based on 801(a)(3);301(ll); PROHIBITED ACT 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.