Violation Code: 3000
FDA Violation
Charge Code: N-RX INACT
Violation Details
- Violation Code (ASC ID)
- 3000
- Charge Code
- N-RX INACT
- Description
- The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
- Legal Section
- 502(e)(1); 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Unilever Uk | Kingston Upon Thames, UNITED KIN | 18 |
| 2 | Colgate Palmolive Company | Boksburg, SOUTH AFRI | 10 |
| 3 | Hemani International | Karachi, PAKISTAN | 10 |
| 4 | Procter & Gamble Co | Cincinnati, UNITED STA | 7 |
| 5 | Takka Inter Service Co., Ltd. | Mueang Samut Prakan, THAILAND | 5 |
| 6 | Sara Lee Philippines, Inc. | Metro Manila, PHILIPPINE | 5 |
| 7 | Colgate-Palmolive Co | East York, CANADA | 5 |
| 8 | S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED | Si Racha, THAILAND | 5 |
| 9 | Elida Pond'S (Pty) Ltd | Durban, SOUTH AFRI | 5 |
| 10 | Hamdard Laboratories (India) | Imt Manesar, INDIA | 4 |
| 11 | Lever Ponds Ltd Product Devlpmnt | Umhlanga, SOUTH AFRI | 4 |
| 12 | Revlon Intl Inc | New York, UNITED STA | 4 |
| 13 | Hindustan Unilever Ltd | Assam, INDIA | 4 |
| 14 | Shiquline Int'L Co Ltd. | Kwai Chung, HONG KONG | 3 |
| 15 | Shanghai Xinai Hotel Supplies Co., Ltd | Shanghai, CHINA | 3 |
| 16 | Dermalogica, LLC | Carson, UNITED STA | 3 |
| 17 | Procter & Gamble Manufacturing GmbH | Marktheidenfeld, GERMANY | 3 |
| 18 | Dr Irena Eris S.A. | Piaseczno, POLAND | 3 |
| 19 | ITN Pakistan Export Enterprises | Karachi, PAKISTAN | 3 |
| 20 | HUIZHOU AOGE ENTERPRISE CO LTD | Huizhou, CHINA | 3 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 2/25/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 4/5/2024 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IG01 | Vicco ProductsINDIA |
| 2/2/2024 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99 | HUBPLATFORMSOUTH KORE |
| 6/12/2023 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VAY99 | GARNIER COSMETICSFRANCE |
| 6/12/2023 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RAY04 | |
| 6/12/2023 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RAY04 | |
| 6/12/2023 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY04 | |
| 6/12/2023 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RAY04 | Church & Dwight UK LimitedUNITED KIN |
| 5/15/2023 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY04 | Church & Dwight UK LimitedUNITED KIN |
| 5/15/2023 | SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) 63RBY05 | TRIMB HEALTHCARE ABSWEDEN |
| 4/4/2023 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBJ99 | ISNTREE CO., LTD.SOUTH KORE |
| 10/26/2022 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YBJ99 | Emami LimitedINDIA |
| 3/9/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 1/28/2022 | ANTI-BACTERIAL, N.E.C. 61HBY99 | NAJMAT AL BANADER TRADEING LLCUNITED ARA |
| 2/3/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HBY05 |
Related Violations
Other violations under the same legal section: 502(e)(1); 801(a)(3); Misbranding
| Code | Charge Code | Cases |
|---|---|---|
| 483 | DRUG NAME | 1330 |
Frequently Asked Questions
What is FDA violation code 3000?
3000 is an FDA violation code that indicates: "The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.". This violation is based on 502(e)(1); 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3000?
According to FDA Import Refusal data, there have been 261 import refusals issued for violation code 3000, affecting 148 unique firms.
When was the most recent refusal for violation 3000?
The most recent import refusal for violation 3000 was on February 25, 2025.
What products are commonly refused for violation 3000?
Products commonly refused under violation 3000 include: MISCELLANEOUS PATENT MEDICINES, ETC., DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS), SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3000?
Violation code 3000 is based on 502(e)(1); 801(a)(3); Misbranding 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.