Violation Code: 2020
FDA Violation
Charge Code: LBLG ADVER
Violation Details
- Violation Code (ASC ID)
- 2020
- Charge Code
- LBLG ADVER
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
- Legal Section
- 502(a), 201(n) and 801(a)(3) Misbranding
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/15/2025 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 6/9/2025 | BANDAGE, ELASTIC 80FQM | |
| 6/11/2024 | COOKIE,BISCUIT,WAFER DOUGH, N.E.C. 03MGT99 | ANABTAWI SWEETSJORDAN |
| 6/11/2024 | COOKIE,BISCUIT,WAFER DOUGH, N.E.C. 03MGT99 | ANABTAWI SWEETSJORDAN |
| 6/11/2024 | COOKIE,BISCUIT,WAFER DOUGH, N.E.C. 03MGT99 | ANABTAWI SWEETSJORDAN |
| 12/14/2023 | BANDAGE, ELASTIC 80FQM | |
| 12/14/2023 | DRESSING, WOUND, HYDROPHILIC 79NAC | |
| 10/25/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 10/12/2023 | BANDAGE, ELASTIC 80FQM | |
| 8/11/2023 | DRESSING, WOUND, HYDROPHILIC 79NAC | |
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 3/31/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 12/31/2022 | CETYLPYRIDINIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) 62FBL07 | The Procter & Gamble CompanyUNITED STA |
| 8/9/2022 | GLOVE, PATIENT EXAMINATION, LATEX 80LYY | STGT SR3THAILAND |
Frequently Asked Questions
What is FDA violation code 2020?
2020 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 misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.". This violation is based on 502(a), 201(n) and 801(a)(3) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2020?
According to FDA Import Refusal data, there have been 110 import refusals issued for violation code 2020, affecting 36 unique firms.
When was the most recent refusal for violation 2020?
The most recent import refusal for violation 2020 was on September 15, 2025.
What products are commonly refused for violation 2020?
Products commonly refused under violation 2020 include: TAPE AND BANDAGE, ADHESIVE, BANDAGE, ELASTIC, COOKIE,BISCUIT,WAFER DOUGH, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2020?
Violation code 2020 is based on 502(a), 201(n) and 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.