Violation Code: 330
FDA Violation
Charge Code: UNSAFE COL
Violation Details
- Violation Code (ASC ID)
- 330
- Charge Code
- UNSAFE COL
- Description
- The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
- Legal Section
- 501(a)(4)(B), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Incosmo S.R.L | Biassono, ITALY | 16 |
| 2 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 10 |
| 3 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 10 |
| 4 | Shahnaz Husain Group | New Dehli, INDIA | 10 |
| 5 | COMERCIALIZADORA PEPSICO MEXICO S DE RL | Mexicali, MEXICO | 7 |
| 6 | King Fortress (Hong Kong) Limited | Sha Tin, HONG KONG | 7 |
| 7 | TIL HEALTHCARE PVT LTD | Irugulam Post, INDIA | 6 |
| 8 | DASENLIN FOOD CO., LTD | Jilin, CHINA | 6 |
| 9 | Forest Foods Co., Ltd. | Jilin, CHINA | 6 |
| 10 | Alimentos Maravilla S.A. | Escuintla, GUATEMALA | 5 |
| 11 | Colgate-Palmolive (India) Ltd. | Jhar Majri, INDIA | 5 |
| 12 | COMERZIALIZADORA PEPSICO S DE RL | Saltillo, MEXICO | 5 |
| 13 | Fabrique Par Sivop-C.I. | Abidjan, IVORY COAS | 5 |
| 14 | Patanjali Ayurved Limited | Haridwar, INDIA | 5 |
| 15 | Al-Mawared Natural Beauty Products Corp. | Amman, JORDAN | 5 |
| 16 | Himalaya Wellness Company | Bengaluru, INDIA | 5 |
| 17 | Comercializadora Pepsico Mexico | Cajeme, MEXICO | 4 |
| 18 | Inneov Espana Sa | Madrid, SPAIN | 4 |
| 19 | Classic Cosmetics, LLC | Chatsworth, UNITED STA | 4 |
| 20 | Farm Invest | M. Chernivtsi, UKRAINE | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/20/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCH99 | |
| 1/9/2026 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | cadbury nigeria plcNIGERIA |
| 12/10/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIY99 | Indaco S.p.A.ITALY |
| 11/4/2025 | SAUCES, N.E.C. 37JCE99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/22/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 |
Frequently Asked Questions
What is FDA violation code 330?
330 is an FDA violation code that indicates: "The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).". This violation is based on 501(a)(4)(B), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 330?
According to FDA Import Refusal data, there have been 391 import refusals issued for violation code 330, affecting 210 unique firms.
When was the most recent refusal for violation 330?
The most recent import refusal for violation 330 was on January 20, 2026.
What products are commonly refused for violation 330?
Products commonly refused under violation 330 include: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., CANDY WITHOUT CHOCOLATE N.E.C., MISCELLANEOUS PATENT MEDICINES, ETC., SAUCES, N.E.C., ICE MILK, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 330?
Violation code 330 is based on 501(a)(4)(B), 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.