Violation Code: 313
FDA Violation
Charge Code: HELD INSAN
Violation Details
- Violation Code (ASC ID)
- 313
- Charge Code
- HELD INSAN
- Description
- The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
- Legal Section
- 601(c), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Coty Manufacturing UK Ltd. | Ashford, UNITED KIN | 79 |
| 2 | Fancl Corporation | Kanagawa, JAPAN | 14 |
| 3 | Shanghai Color Art Stationery Company Limited | Qu Shanghai, CHINA | 13 |
| 4 | Zhongshan Metro Cosmetics Ind Co Lt | Zhongshan City, CHINA | 10 |
| 5 | Cesar Gaona Jaramillo | Guayaquil, ECUADOR | 8 |
| 6 | Produits Dave Hamp | Mirabel, CANADA | 7 |
| 7 | SDI Limited | Bayswater, AUSTRALIA | 7 |
| 8 | Baja Fur S A De C V | Tijuana, MEXICO | 7 |
| 9 | Markwins Cosmetic (ShenZhen) Co., Ltd. | Shenzhen, CHINA | 6 |
| 10 | Maxtech Bath & Body Factory | Shenzhen, CHINA | 6 |
| 11 | Parbel Inc | Miami, UNITED STA | 5 |
| 12 | Zhuhai Maxis Cosmetics Prod.Co. Ltd | Zhuhai City, CHINA | 5 |
| 13 | S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED | Si Racha, THAILAND | 4 |
| 14 | Northern Cosmetics | Mississauga, CANADA | 3 |
| 15 | New Health Products Co Ltd | Taipei, TAIWAN | 3 |
| 16 | Produits Dave Hampton | Mirabel, CANADA | 3 |
| 17 | Schwan Cosmetics Cr S R.O. | Domoradice, CZECH REPU | 2 |
| 18 | Taizhou Kanglin Health Protection Products Co., Ltd. | Taizhou, CHINA | 2 |
| 19 | Intercos Cosmetics (Suzhou) Co., Ltd. | Suzhou, CHINA | 2 |
| 20 | Molcan Corp | Richmond Hill, CANADA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/7/2022 | OTHER EYE MAKEUP PREPARATIONS, N.E.C. 53CJ99 | LASH BY HOLLYVIETNAM |
| 8/21/2020 | MASCARA (EYE MAKEUP PREPARATIONS) 53CY06 | |
| 1/24/2019 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 9/7/2018 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JD01 | Medline Industries, LPUNITED STA |
| 8/13/2018 | EYELINER (EYE MAKEUP PREPARATIONS) 53CY02 | Cosmetic Colors Sa De CvMEXICO |
| 9/8/2017 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 4/21/2017 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YH99 | ITN FoodCANADA |
| 4/21/2017 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YH99 | ITN FoodCANADA |
| 12/21/2016 | OTHER EYE MAKEUP PREPARATIONS, N.E.C. 53CF99 | TONYMOLY Co., Ltd.SOUTH KORE |
| 12/21/2016 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LC06 | TONYMOLY Co., Ltd.SOUTH KORE |
| 1/7/2016 | EYELINER (EYE MAKEUP PREPARATIONS) 53CD02 | |
| 12/2/2015 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LC99 | Al Hadaeq PerfumeUNITED ARA |
| 9/21/2015 | EYELINER (EYE MAKEUP PREPARATIONS) 53CK02 | Schwan Cosmetics Cr S R.O.CZECH REPU |
| 8/24/2015 | EYELINER (EYE MAKEUP PREPARATIONS) 53CK02 | Schwan Cosmetics Cr S R.O.CZECH REPU |
| 4/27/2015 | COLOR FOR COSMETIC (NOT CERTIFIED) 50BHY60 | Jinmei Co LtdCHINA |
Frequently Asked Questions
What is FDA violation code 313?
313 is an FDA violation code that indicates: "The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.". This violation is based on 601(c), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 313?
According to FDA Import Refusal data, there have been 243 import refusals issued for violation code 313, affecting 64 unique firms.
When was the most recent refusal for violation 313?
The most recent import refusal for violation 313 was on October 7, 2022.
What products are commonly refused for violation 313?
Products commonly refused under violation 313 include: OTHER EYE MAKEUP PREPARATIONS, N.E.C., MASCARA (EYE MAKEUP PREPARATIONS), EYE SHADOW (EYE MAKEUP PREPARATIONS), BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS), EYELINER (EYE MAKEUP PREPARATIONS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 313?
Violation code 313 is based on 601(c), 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.