Violation Code: 3845
FDA Violation
Charge Code: DRG REF EI
Violation Details
- Violation Code (ASC ID)
- 3845
- Charge Code
- DRG REF EI
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
- Legal Section
- 801(a)(3), 501(j); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/12/2025 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LY03 | GDK Cosmetics Co., Ltd.SOUTH KORE |
| 11/10/2025 | TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) 61WAR31 | |
| 10/27/2025 | SILDENAFIL CITRATE (REGULATOR) 65PIY02 | |
| 10/8/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | Seoul Cosmetics Co., Ltd.SOUTH KORE |
| 8/21/2025 | HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) 53EY01 | Seoul Cosmetics Co., Ltd.SOUTH KORE |
| 8/21/2025 | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53EY99 | Seoul Cosmetics Co., Ltd.SOUTH KORE |
| 8/12/2025 | ANTI-MICROBIAL N.E.C. 62HAL99 | |
| 8/12/2025 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 8/8/2025 | FLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) 61FOY35 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 | |
| 7/8/2025 | PEPTIDE N.E.C. 56FCT99 |
Frequently Asked Questions
What is FDA violation code 3845?
3845 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 of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.". This violation is based on 801(a)(3), 501(j); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3845?
According to FDA Import Refusal data, there have been 102 import refusals issued for violation code 3845, affecting 40 unique firms.
When was the most recent refusal for violation 3845?
The most recent import refusal for violation 3845 was on November 12, 2025.
What products are commonly refused for violation 3845?
Products commonly refused under violation 3845 include: FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC), SILDENAFIL CITRATE (REGULATOR), OTHER SKIN CARE PREPARATIONS, N.E.C., HAIR CONDITIONERS (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 3845?
Violation code 3845 is based on 801(a)(3), 501(j); 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.