Violation Code: 331
FDA Violation
Charge Code: DR QUALITC
Violation Details
- Violation Code (ASC ID)
- 331
- Charge Code
- DR QUALITC
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
- Legal Section
- 501(c), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Holyayu Research Center | Karnal, INDIA | 12 |
| 2 | Incredible Products, SA de CV | Guadalajara, MEXICO | 10 |
| 3 | Nouvelle Parfumerie Gandour Cote Di | Abidjan, IVORY COAS | 7 |
| 4 | Megasol Cosmetic GmbH | Fohren, GERMANY | 7 |
| 5 | Margarita Martinez | Nezahualcoyotl, MEXICO | 5 |
| 6 | Nehal K. Shah | Mumbai, INDIA | 5 |
| 7 | Dhanavantnari Ayurredic | Nagar, INDIA | 5 |
| 8 | Panalpina Ag | Basel, SWITZERLAN | 4 |
| 9 | DREAM COSMETICS | Abigian, IVORY COAS | 4 |
| 10 | ShangRao Chunyu Technology Co., Ltd. | Shangrao, CHINA | 4 |
| 11 | Nirmala | Madras, INDIA | 4 |
| 12 | DongBang Cosmetics Co., Ltd. | Seo District, SOUTH KORE | 4 |
| 13 | Laavo Clean, S.A. de C.V. | Ciudad Apodaca, MEXICO | 3 |
| 14 | Meunerie Robitaille | Farnham, CANADA | 3 |
| 15 | Guangzhou Youxing Cosmetic Co., Ltd | Guangzhou, CHINA | 3 |
| 16 | Laboratory Mck | Mexico, MEXICO | 3 |
| 17 | Biologische Heilmittel Heel Gmbh | Baden-Baden, GERMANY | 3 |
| 18 | A Kopman | North York, CANADA | 2 |
| 19 | Staufen & Pharma | Goppingen, GERMANY | 2 |
| 20 | Glaxo Wellcome S.A. | Aranda De Duero, SPAIN | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/8/2025 | LEVOTHYROXINE SODIUM (THYROID HORMONE) 66JCA01 | |
| 3/13/2025 | LEVOTHYROXINE SODIUM (THYROID HORMONE) 66JCA01 | |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 3/14/2024 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 9/7/2023 | SUPPRESSANT N.E.C. 66FDY99 | |
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 12/15/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 9/1/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 9/1/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 9/1/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 9/1/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 6/22/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | |
| 6/22/2021 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 |
Related Violations
Other violations under the same legal section: 501(c), 801(a)(3); ADULTERATION
| Code | Charge Code | Cases |
|---|---|---|
| 235 | NOT IMPACT | 2590 |
Frequently Asked Questions
What is FDA violation code 331?
331 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.". This violation is based on 501(c), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 331?
According to FDA Import Refusal data, there have been 294 import refusals issued for violation code 331, affecting 202 unique firms.
When was the most recent refusal for violation 331?
The most recent import refusal for violation 331 was on April 8, 2025.
What products are commonly refused for violation 331?
Products commonly refused under violation 331 include: LEVOTHYROXINE SODIUM (THYROID HORMONE), SHAMPOOS (HAIR PREPARATIONS, NON-COLORING). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 331?
Violation code 331 is based on 501(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.