Violation Code: 197
FDA Violation
Charge Code: COSM COLOR
Violation Details
- Violation Code (ASC ID)
- 197
- Charge Code
- COSM COLOR
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
- Legal Section
- 601(e), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BROW CODE PTY LTD | Molendinar, AUSTRALIA | 487 |
| 2 | Jye Leh Cosmetics Co Ltd | Taiwan City, TAIWAN | 197 |
| 3 | Unilever Lever Faberge Deutschland | Mannheim, GERMANY | 182 |
| 4 | Dasini Plastic Toys Factory | Shantou, CHINA | 86 |
| 5 | Zhejiang Yasili Cosmetics Co., Ltd. | Jinhua, CHINA | 83 |
| 6 | Unilever Deutschland | Buxtehude, GERMANY | 78 |
| 7 | Nvey Eco Cosmetics Pty Ltd | Melbourne, AUSTRALIA | 74 |
| 8 | Naturelle LLC | Ras Al Khaimah, UNITED ARA | 73 |
| 9 | Unilever Philippines, Inc. - Cavite Factory | Calabarzon, PHILIPPINE | 67 |
| 10 | Hemani International | Karachi, PAKISTAN | 55 |
| 11 | ANN ANN INC | Tainan City, TAIWAN | 54 |
| 12 | Interwork Korea Co., Ltd | Kyunggi-Do, SOUTH KORE | 48 |
| 13 | Dariya Corporation | Nagoya, JAPAN | 47 |
| 14 | ORGANIC NAILS | Zapopan, MEXICO | 46 |
| 15 | A.W. Faber-Castell Cosmetics Gmbh | Stein, GERMANY | 45 |
| 16 | Cho Chuang Industrial Co., Ltd. | Yung Kang, TAIWAN | 44 |
| 17 | Colgate Palmolive, S.A. de C.V. | Mexico City, MEXICO | 42 |
| 18 | Puig France S A S | Paris, FRANCE | 39 |
| 19 | Hindustan Unilever Ltd. | Unknown, INDIA | 37 |
| 20 | Unilever Mexico S de R.L. de C.V. | Jiutepec, MEXICO | 36 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 1/22/2026 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | Beiersdorf AGGERMANY |
| 1/21/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CY03 | |
| 1/18/2026 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LG03 | |
| 1/14/2026 | OTHER EYE MAKEUP PREPARATIONS, N.E.C. 53CD99 | |
| 1/14/2026 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YH99 | |
| 1/14/2026 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YH99 | |
| 1/13/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 1/9/2026 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JD01 | Reckitt BenckiserINDIA |
| 1/9/2026 | OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. 53JY99 | |
| 1/9/2026 | OTHER FRAGRANCE PREPARATIONS, N.E.C. 53DY99 | LAKME LEVER PVT LTDINDIA |
| 1/9/2026 | COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) 53DY01 | LAKME LEVER PVT LTDINDIA |
| 1/9/2026 | OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. 53JY99 | |
| 1/9/2026 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | CAVINKARE PVT LTDINDIA |
| 1/9/2026 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | CAVINKARE PVT LTDINDIA |
Frequently Asked Questions
What is FDA violation code 197?
197 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 a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).". This violation is based on 601(e), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 197?
According to FDA Import Refusal data, there have been 6532 import refusals issued for violation code 197, affecting 1375 unique firms.
When was the most recent refusal for violation 197?
The most recent import refusal for violation 197 was on January 22, 2026.
What products are commonly refused for violation 197?
Products commonly refused under violation 197 include: EYE SHADOW (EYE MAKEUP PREPARATIONS), BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS), FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), OTHER EYE MAKEUP PREPARATIONS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 197?
Violation code 197 is based on 601(e), 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.