Violation Code: 3881
FDA Violation
Charge Code: COSMETFPLA
Violation Details
- Violation Code (ASC ID)
- 3881
- Charge Code
- COSMETFPLA
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
- Legal Section
- 1454(c)(3)(B), 1456, 801(a)(3)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BROW CODE PTY LTD | Molendinar, AUSTRALIA | 192 |
| 2 | Unilever Lever Faberge Deutschland | Mannheim, GERMANY | 94 |
| 3 | Unilever Deutschland | Buxtehude, GERMANY | 32 |
| 4 | UL SKIN SCIENCES INC | Mandaluyong City Metr, PHILIPPINE | 22 |
| 5 | Reckitt Benckiser | Uttarakhand, INDIA | 18 |
| 6 | Puig France S A S | Paris, FRANCE | 12 |
| 7 | DREAM COSMETICS | Abigian, IVORY COAS | 12 |
| 8 | Dariya Corporation | Nagoya, JAPAN | 12 |
| 9 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 11 |
| 10 | Dey'S Medical Stores Pvt Ltd., | Kolkata, INDIA | 10 |
| 11 | ORGANIC NAILS | Zapopan, MEXICO | 10 |
| 12 | QUAN TONG COSMERTICS CO.,LTD | Guangzhou, CHINA | 10 |
| 13 | Supreme Worldwide | -Thane, INDIA | 9 |
| 14 | Godrej Consumer Products Ltd. | Mumbai, INDIA | 9 |
| 15 | COSMAX, INC. | Hwaseong-si, SOUTH KORE | 8 |
| 16 | Patanjali Ayurved Limited | Haridwar, INDIA | 8 |
| 17 | ZHEJIANG B & F COSMETICS CO LTD | Zhejiang, CHINA | 8 |
| 18 | Hemani International | Karachi, PAKISTAN | 8 |
| 19 | Karnataka Soaps & Detergents Ltd. | Bangalore, INDIA | 7 |
| 20 | PATANJALI AYURVED LIMITED | Haridwar, INDIA | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
| 1/15/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | UL SKIN SCIENCES INCPHILIPPINE |
Frequently Asked Questions
What is FDA violation code 3881?
3881 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 contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.". This violation is based on 1454(c)(3)(B), 1456, 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3881?
According to FDA Import Refusal data, there have been 749 import refusals issued for violation code 3881, affecting 138 unique firms.
When was the most recent refusal for violation 3881?
The most recent import refusal for violation 3881 was on January 15, 2026.
What products are commonly refused for violation 3881?
Products commonly refused under violation 3881 include: FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3881?
Violation code 3881 is based on 1454(c)(3)(B), 1456, 801(a)(3) 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.