Violation Code: 115
FDA Violation
Charge Code: DR QUALITY
Violation Details
- Violation Code (ASC ID)
- 115
- Charge Code
- DR QUALITY
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
- Legal Section
- 501(b), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Pharma Exp | Montreal, CANADA | 84 |
| 2 | Incredible Products, SA de CV | Guadalajara, MEXICO | 10 |
| 3 | Eclipse Limited | Gore, NEW ZEALAN | 9 |
| 4 | Genesis Partnership Company SA | Villa Nueva, GUATEMALA | 9 |
| 5 | Pharmacia Healthcare Limited | Gujarat, INDIA | 5 |
| 6 | Mayinglong Pharmaceutical Group Co., Ltd. | Wuhan, CHINA | 4 |
| 7 | Sinerga S.p.A. | Gorla Maggiore, ITALY | 4 |
| 8 | Zhejiang Ludao Technology Co., Ltd. | Taizhou, CHINA | 3 |
| 9 | Dabur India Limited | Silvassa, INDIA | 3 |
| 10 | Glaxo Wellcome S.A. | Aranda De Duero, SPAIN | 3 |
| 11 | Bayer de Mexico, S.A. de C.V. | Lerma, MEXICO | 3 |
| 12 | Himalaya Wellness Company | Bengaluru, INDIA | 3 |
| 13 | Hebei Changshan Biochemical Pharmaceutical Co., Ltd. | Shijiazhuang, CHINA | 3 |
| 14 | Glaxo Operations UK Limited | Liverpool, UNITED KIN | 3 |
| 15 | Albert David Ltd. | Kolkata, INDIA | 3 |
| 16 | Glenwood, LLC | Englewood, UNITED STA | 2 |
| 17 | Hallmark | Delhi, INDIA | 2 |
| 18 | Herbion Pakistan (Pvt.) Ltd. | Karachi, PAKISTAN | 2 |
| 19 | Aso Pharmaceutical Company, Ltd | Kikuchi-Gun, JAPAN | 2 |
| 20 | Foreign Trading Co., The | Guangzhou, CHINA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/22/2025 | ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) 61JCA08 | |
| 8/18/2025 | HEPARIN SODIUM (ANTI-COAGULANT) 61LCS08 | |
| 8/18/2025 | INTRODUCER, SYRINGE NEEDLE 80KZH | LILLY USAUNITED STA |
| 7/8/2024 | HEPARIN SODIUM (ANTI-COAGULANT) 61LCP08 | Gland Pharma LimitedINDIA |
| 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 | |
| 7/19/2023 | MENTHOL (ANTI-PRURITIC) 62MMA08 | Jakemans (Confectioners) Ltd.UNITED KIN |
| 2/27/2023 | LEVETIRACETAM (ANTI-CONVULSANT) 61MCB42 | |
| 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 |
Frequently Asked Questions
What is FDA violation code 115?
115 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.". This violation is based on 501(b), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 115?
According to FDA Import Refusal data, there have been 236 import refusals issued for violation code 115, affecting 91 unique firms.
When was the most recent refusal for violation 115?
The most recent import refusal for violation 115 was on September 22, 2025.
What products are commonly refused for violation 115?
Products commonly refused under violation 115 include: ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC), HEPARIN SODIUM (ANTI-COAGULANT), INTRODUCER, SYRINGE NEEDLE, 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 115?
Violation code 115 is based on 501(b), 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.