Violation Code: 185
FDA Violation
Charge Code: REDUCED
Violation Details
- Violation Code (ASC ID)
- 185
- Charge Code
- REDUCED
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
- Legal Section
- 501(d)(1), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Incredible Products, SA de CV | Guadalajara, MEXICO | 10 |
| 2 | Sinerga S.p.A. | Gorla Maggiore, ITALY | 3 |
| 3 | Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd. | Shanghai, CHINA | 2 |
| 4 | Laboratorios Jaloma S.A. de C.V. | Guadalajara, MEXICO | 1 |
| 5 | Sanofi-Pasteur | Chicago, UNITED STA | 1 |
| 6 | Maquiladora Miniara SA de CV | Coyotepec, MEXICO | 1 |
| 7 | Genesis Partnership Company SA | Villa Nueva, GUATEMALA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 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 | |
| 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 | |
| 5/11/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HBL05 | |
| 4/9/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | Sinerga S.p.A.ITALY |
| 4/9/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | Sinerga S.p.A.ITALY |
| 4/9/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | Sinerga S.p.A.ITALY |
| 12/18/2020 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | Genesis Partnership Company SAGUATEMALA |
Frequently Asked Questions
What is FDA violation code 185?
185 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 be a drug that a substance has been mixed or packed with so as to reduce its strength.". This violation is based on 501(d)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 185?
According to FDA Import Refusal data, there have been 19 import refusals issued for violation code 185, affecting 7 unique firms.
When was the most recent refusal for violation 185?
The most recent import refusal for violation 185 was on March 14, 2024.
What products are commonly refused for violation 185?
Products commonly refused under violation 185 include: SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), SUPPRESSANT N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 185?
Violation code 185 is based on 501(d)(1), 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.