Violation Code: 3761
FDA Violation
Charge Code: FILTH
Violation Details
- Violation Code (ASC ID)
- 3761
- Charge Code
- FILTH
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
- Legal Section
- 501(a)(1)Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Sperian Eye & Face Protection Inc | Platteville, UNITED STA | 10 |
| 2 | Fresenius Medical Care de Mexico, SA de CV | Zapopan, MEXICO | 8 |
| 3 | Beiersdorf Manufacturing Mexico SA de CV | Silao, MEXICO | 3 |
| 4 | PLANTAS MEDICINALES DE MEXICO | DELEGACION XOCHIMILCO C.P, MEXICO | 2 |
| 5 | Pt. Shamrock Manufacturing Corp. | N. Sumatra, INDONESIA | 1 |
| 6 | Sterling Biotech Limited | Gujarat, INDIA | 1 |
| 7 | Contacare Ophthalmics & Diagnostics | Dabhasa, INDIA | 1 |
| 8 | Healthcaps India Limited | New Delhi, INDIA | 1 |
| 9 | Shantou Chenghai Hua Nuo Intelligent Technology Co., Ltd. | Shantou, CHINA | 1 |
| 10 | Beautiful Earth | Pretoria, SOUTH AFRI | 1 |
| 11 | CV. VISI INDO PRIMA | Yogyakarta, INDONESIA | 1 |
| 12 | Voyant Beauty, Inc. | Etobicoke, CANADA | 1 |
| 13 | SAVVY CARE & COSMETICS PVT. LTD. | Navi Mumbai, INDIA | 1 |
| 14 | Industria Farmaceutica Andromaco S.A. de C.V. | Zona Industrial Parque Industrial Toluca 2000, MEXICO | 1 |
| 15 | Fresenius Kabi (Brunna Facility) AB | Kungsangen, SWEDEN | 1 |
| 16 | Delta Pharma Inc. | Dorval, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/14/2025 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBY99 | |
| 11/6/2025 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBY99 | |
| 9/24/2025 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBY99 | |
| 12/18/2024 | GLUCOCORTICOID N.E.C. 64LBY99 | |
| 1/17/2024 | GLOVE, PATIENT EXAMINATION, LATEX 80LYY | Pt. Shamrock Manufacturing Corp.INDONESIA |
| 9/8/2023 | BENZOYL PEROXIDE (KERATOLYTIC) 64XAY03 | Voyant Beauty, Inc.CANADA |
| 6/10/2022 | CHILDREN NOVELTY EYE MAKEUP KITS 53CH09 | |
| 9/19/2019 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBR99 | CV. VISI INDO PRIMAINDONESIA |
| 8/6/2019 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBR99 | |
| 8/6/2019 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBR99 | |
| 1/9/2018 | FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) 63XAY12 | |
| 11/13/2017 | ZINC GELATIN (PROTECTANT) 65LAJ13 | |
| 2/3/2017 | WATER, PURIFIED (EYEWASH) 65FAK06 | Sperian Eye & Face Protection IncUNITED STA |
| 2/3/2017 | WATER, PURIFIED (EYEWASH) 65FAK06 | Sperian Eye & Face Protection IncUNITED STA |
| 2/3/2017 | WATER, PURIFIED (EYEWASH) 65FAK06 | Sperian Eye & Face Protection IncUNITED STA |
Frequently Asked Questions
What is FDA violation code 3761?
3761 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance". This violation is based on 501(a)(1)Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3761?
According to FDA Import Refusal data, there have been 35 import refusals issued for violation code 3761, affecting 16 unique firms.
When was the most recent refusal for violation 3761?
The most recent import refusal for violation 3761 was on November 14, 2025.
What products are commonly refused for violation 3761?
Products commonly refused under violation 3761 include: ULTRAVIOLET SCREEN/SUNSCREEN N.E.C., GLUCOCORTICOID N.E.C., GLOVE, PATIENT EXAMINATION, LATEX. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3761?
Violation code 3761 is based on 501(a)(1)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.