Violation Code: 3560
FDA Violation
Charge Code: SUPPL GMP
Violation Details
- Violation Code (ASC ID)
- 3560
- Charge Code
- SUPPL GMP
- Description
- The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
- Legal Section
- 402(g)(1), Adulteration, 801(a)(3), Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Forza Vitale Italia S.r.l. | Corato, ITALY | 102 |
| 2 | Tonic Life S de RL | Irapuato, MEXICO | 20 |
| 3 | VAHDAM TEAS PVT LT | Noida, INDIA | 19 |
| 4 | Marudhar Impex | Ahmedabad, INDIA | 16 |
| 5 | Parkacre Limited | Gainsborough, UNITED KIN | 15 |
| 6 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 14 |
| 7 | NuEra Nutraceutical Inc | Richmond, CANADA | 11 |
| 8 | Metabolics Ltd | Devizes, UNITED KIN | 11 |
| 9 | Mas Natural Salud Y Bienestar | Irapuato, MEXICO | 10 |
| 10 | Alopecil Corporation, S.R.L. | Santo Domingo, DOMINICAN | 10 |
| 11 | Phyto Science | Bandar Baru Bangi, MALAYSIA | 8 |
| 12 | PLANTAFOOD MEDICAL GMBH | Leiningen, GERMANY | 8 |
| 13 | Minature Wellness Pvt Ltd | Ahmedabad, INDIA | 7 |
| 14 | Patanjali Ayurved Limited | Haridwar, INDIA | 6 |
| 15 | HERBALAND NATURALS INC | Richmond, CANADA | 6 |
| 16 | DATELINE KAVA | Suva, FIJI | 4 |
| 17 | Goodcare Pharma Pvt. Ltd. | West Bengal, INDIA | 4 |
| 18 | Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda | Bebedouro, BRAZIL | 4 |
| 19 | Dr Ma's Laboratories, Inc. | Burnaby, CANADA | 4 |
| 20 | Laboratorio Mas Natural S. de R.L. de C.V. | Irapuato, MEXICO | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/21/2026 | VITAMIN, N.E.C. 54ABF99 | Parkacre LimitedUNITED KIN |
| 1/21/2026 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYT99 | Parkacre LimitedUNITED KIN |
| 1/21/2026 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | Parkacre LimitedUNITED KIN |
| 1/21/2026 | TEA, N.E.C. 31KYT99 | Tonic Life S de RLMEXICO |
| 1/21/2026 | COFFEE, INSTANT 31AYT03 | Tonic Life S de RLMEXICO |
| 1/20/2026 | TEA, BLACK 31KYY01 | Tonic Life S de RLMEXICO |
| 1/14/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCH99 | Tonic Life S de RLMEXICO |
| 1/14/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCL99 | Prime Health ProductsCANADA |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Xtend-Life Group LimitedNEW ZEALAN |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Xtend-Life Group LimitedNEW ZEALAN |
| 1/12/2026 | TEA, INSTANT, PLAIN 31KYT30 | Tonic Life S de RLMEXICO |
| 1/9/2026 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | Parkacre LimitedUNITED KIN |
| 1/9/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Parkacre LimitedUNITED KIN |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Parkacre LimitedUNITED KIN |
| 1/7/2026 | GLUCOSAMINE SULFATE (HERBAL AND BOTANICALS, NOT TEAS II) 54KCE13 | Tonic Life S de RLMEXICO |
Frequently Asked Questions
What is FDA violation code 3560?
3560 is an FDA violation code that indicates: "The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.". This violation is based on 402(g)(1), Adulteration, 801(a)(3), Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3560?
According to FDA Import Refusal data, there have been 344 import refusals issued for violation code 3560, affecting 54 unique firms.
When was the most recent refusal for violation 3560?
The most recent import refusal for violation 3560 was on January 21, 2026.
What products are commonly refused for violation 3560?
Products commonly refused under violation 3560 include: VITAMIN, N.E.C., FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS, TEA, N.E.C., COFFEE, INSTANT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3560?
Violation code 3560 is based on 402(g)(1), Adulteration, 801(a)(3), Adulteration 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.