Violation Code: 2800
FDA Violation
Charge Code: POSS N/STR
Violation Details
- Violation Code (ASC ID)
- 2800
- Charge Code
- POSS N/STR
- Description
- The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
- Legal Section
- 501(a)(1); 801(a)(3) ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu, CHINA | 31 |
| 2 | Zhejiang Bangli Medical Products Co., Ltd | Yongkang, CHINA | 25 |
| 3 | Dhp Co., Ltd | Yiwu, CHINA | 10 |
| 4 | WELONG PLASTIC PRODUCTS CO, LTD | Ningbo, CHINA | 8 |
| 5 | Allmed Medical Products Co., Ltd. (Zhijiang Factory) | Yichang, CHINA | 7 |
| 6 | YIWU BANGMEI MEDICAL PRODUCTS | Jinhua, CHINA | 7 |
| 7 | Chain Medical Products Co., Ltd. | Ningbo, CHINA | 7 |
| 8 | White Medical Ind., Inc. | Ulsan, SOUTH KORE | 5 |
| 9 | Everaid Co., Ltd. | Yangsan-si, SOUTH KORE | 5 |
| 10 | GEO Medical Co., Ltd. | Buk, SOUTH KORE | 4 |
| 11 | A.R Medicom Inc (Shanghai) Ltd. | Shanghai, CHINA | 3 |
| 12 | Yangzhou Super-Union Medical Material Co., Ltd. | YIZHENG, CHINA | 3 |
| 13 | Industrias Jaloma S.A. de C.V. | Guadalajara, MEXICO | 3 |
| 14 | Eco-Med Pharmaceuticals, Inc. | Etobicoke, CANADA | 3 |
| 15 | 3M Edumex, S.A. De Cv | Juarez, MEXICO | 3 |
| 16 | NANJING 3H MEDICAL PRODUCTS CO., LTD | Nanjing, CHINA | 2 |
| 17 | Fabrik Gmbh Co Kg | Stolzenau, GERMANY | 2 |
| 18 | Arsons Industries | Lahore, PAKISTAN | 2 |
| 19 | Planet Hong Kong International Company | Hong Kong, CHINA | 1 |
| 20 | Sato Pharmaceutical Co., Ltd | Tokyo, JAPAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 12/6/2021 | TRANSDUCER, ULTRASONIC, DIAGNOSTIC 90ITX | |
| 12/6/2021 | TRANSDUCER, ULTRASONIC, DIAGNOSTIC 90ITX | |
| 12/6/2021 | TRANSDUCER, ULTRASONIC, DIAGNOSTIC 90ITX | |
| 11/24/2020 | LENS, CONTACT (DISPOSABLE) 86MVN | GEO Medical Co., Ltd.SOUTH KORE |
| 9/10/2020 | DRESSING, WOUND, OCCLUSIVE 79NAD | |
| 7/13/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/29/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/26/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/26/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/26/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/25/2020 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 6/25/2020 | FIRST AID KIT WITHOUT DRUG 79OHO |
Frequently Asked Questions
What is FDA violation code 2800?
2800 is an FDA violation code that indicates: "The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms". This violation is based on 501(a)(1); 801(a)(3) ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2800?
According to FDA Import Refusal data, there have been 144 import refusals issued for violation code 2800, affecting 32 unique firms.
When was the most recent refusal for violation 2800?
The most recent import refusal for violation 2800 was on March 31, 2023.
What products are commonly refused for violation 2800?
Products commonly refused under violation 2800 include: TAPE AND BANDAGE, ADHESIVE, TRANSDUCER, ULTRASONIC, DIAGNOSTIC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2800?
Violation code 2800 is based on 501(a)(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.