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 | VAHDAM TEAS PVT LT | Noida, INDIA | 19 |
| 3 | Marudhar Impex | Ahmedabad, INDIA | 16 |
| 4 | Tonic Life S de RL | Irapuato, MEXICO | 14 |
| 5 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 14 |
| 6 | Metabolics Ltd | Devizes, UNITED KIN | 11 |
| 7 | NuEra Nutraceutical Inc | Richmond, CANADA | 11 |
| 8 | Mas Natural Salud Y Bienestar | Irapuato, MEXICO | 10 |
| 9 | Alopecil Corporation, S.R.L. | Santo Domingo, DOMINICAN | 10 |
| 10 | Parkacre Limited | Gainsborough, UNITED KIN | 9 |
| 11 | PLANTAFOOD MEDICAL GMBH | Leiningen, GERMANY | 8 |
| 12 | Phyto Science | Bandar Baru Bangi, MALAYSIA | 8 |
| 13 | Minature Wellness Pvt Ltd | Ahmedabad, INDIA | 7 |
| 14 | HERBALAND NATURALS INC | Richmond, CANADA | 6 |
| 15 | Patanjali Ayurved Limited | Haridwar, INDIA | 6 |
| 16 | Laboratorio Mas Natural S. de R.L. de C.V. | Irapuato, MEXICO | 4 |
| 17 | Novonesis AS | Hvidovre, DENMARK | 4 |
| 18 | DATELINE KAVA | Suva, FIJI | 4 |
| 19 | Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda | Bebedouro, BRAZIL | 4 |
| 20 | Pharmalab 1982 Inc. Dba. Ideal Protein | Levis, CANADA | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | COFFEE, INSTANT 31AGT03 | Tonic Life S de RLMEXICO |
| 12/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | SANUM-Kehlbeck GmbH & Co. KGGERMANY |
| 12/17/2025 | MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) 54FBH20 | |
| 12/17/2025 | MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) 54FBH20 | |
| 12/9/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYT99 | Parkacre LimitedUNITED KIN |
| 12/8/2025 | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) 54FGF94 | |
| 12/5/2025 | MAGNESIUM (MINERAL) 54BBY08 | NuEra Nutraceutical IncCANADA |
| 12/5/2025 | VITAMIN B2 (RIBOFLAVIN) 54ACY03 | NuEra Nutraceutical IncCANADA |
| 12/2/2025 | PROTEIN N.E.C. 54CCR99 | Parkacre LimitedUNITED KIN |
| 12/2/2025 | PROTEIN N.E.C. 54CCR99 | Parkacre LimitedUNITED KIN |
| 12/2/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYT99 | Parkacre LimitedUNITED KIN |
| 11/25/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCH99 | |
| 11/25/2025 | WHEY (DRIED 09EYY17 | Parkacre LimitedUNITED KIN |
| 11/25/2025 | PROTEIN N.E.C. 54CCR99 | Parkacre LimitedUNITED KIN |
| 11/21/2025 | MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) 41EYY99 | Parkacre LimitedUNITED KIN |
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 329 import refusals issued for violation code 3560, affecting 52 unique firms.
When was the most recent refusal for violation 3560?
The most recent import refusal for violation 3560 was on December 31, 2025.
What products are commonly refused for violation 3560?
Products commonly refused under violation 3560 include: COFFEE, INSTANT, VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P), FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS. 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.