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 | Shahnaz Husain Group | New Dehli, INDIA | 10 |
| 3 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 10 |
| 4 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 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 | Al-Mawared Natural Beauty Products Corp. | Amman, JORDAN | 5 |
| 10 | Fabrique Par Sivop-C.I. | Abidjan, IVORY COAS | 5 |
| 11 | Colgate-Palmolive (India) Ltd. | Jhar Majri, INDIA | 5 |
| 12 | COMERZIALIZADORA PEPSICO S DE RL | Saltillo, MEXICO | 5 |
| 13 | Patanjali Ayurved Limited | Haridwar, INDIA | 5 |
| 14 | Alimentos Maravilla S.A. | Escuintla, GUATEMALA | 5 |
| 15 | Himalaya Wellness Company | Bengaluru, INDIA | 5 |
| 16 | Classic Cosmetics, LLC | Chatsworth, UNITED STA | 4 |
| 17 | Farm Invest | M. Chernivtsi, UKRAINE | 4 |
| 18 | Comercializadora Pepsico Mexico | Cajeme, MEXICO | 4 |
| 19 | Bio Kor Metics Ltd | Bneibrak, ISRAEL | 4 |
| 20 | Ibeauty S.R.L. | Curno, ITALY | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 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 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 10/10/2025 | ICE MILK, N.E.C. 13CGT99 | |
| 9/12/2025 | SYRUPS AND MOLASSES, N.E.C. 36BHT99 | |
| 6/17/2025 | SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED 29AGT09 | Alimentos Maravilla S.A.GUATEMALA |
| 6/17/2025 | SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED 29AGT09 | Alimentos Maravilla S.A.GUATEMALA |
| 6/17/2025 | SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED 29AGT09 | Alimentos Maravilla S.A.GUATEMALA |
| 6/17/2025 | SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED 29AGT09 | Alimentos Maravilla S.A.GUATEMALA |
| 6/17/2025 | SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED 29AGT09 | Alimentos Maravilla S.A.GUATEMALA |
| 6/11/2025 | GUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VCT04 |
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 383 import refusals issued for violation code 330, affecting 207 unique firms.
When was the most recent refusal for violation 330?
The most recent import refusal for violation 330 was on December 10, 2025.
What products are commonly refused for violation 330?
Products commonly refused under violation 330 include: 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.