Violation Code: 3896
FDA Violation
Charge Code: NOCONTACT
Violation Details
- Violation Code (ASC ID)
- 3896
- Charge Code
- NOCONTACT
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
- Legal Section
- 502(x),801(a)(3); MISBRANDING
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/1/2024 | STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY06 | GLAXOSMITHKLINEUNITED STA |
| 10/24/2024 | DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) 61XBL18 | MEIR RUBCANADA |
| 8/27/2024 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YY99 | BENEFIT COSMETICS LIMITEDUNITED KIN |
| 8/27/2024 | MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IY02 | OPTIMA NATURAL SRLITALY |
| 8/27/2024 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YY99 | BENEFIT COSMETICS LIMITEDUNITED KIN |
| 8/27/2024 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YY99 | VITABIOTICS LIMITEDUNITED KIN |
| 8/27/2024 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YY99 | NIVEA BEIERSDORF UK LTDUNITED KIN |
| 1/5/2024 | ANTI-CHOLINERGIC, N.E.C. 61KBK99 | Boiron Of Canada IncCANADA |
| 9/7/2023 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Gsk Consumer HealthcareUNITED KIN |
| 10/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 8/16/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 6/4/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 5/19/2021 | SILDENAFIL CITRATE (REGULATOR) 65PDY02 | Veysi TopuzTURKEY |
| 5/11/2021 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IY01 | |
| 5/11/2021 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 |
Frequently Asked Questions
What is FDA violation code 3896?
3896 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 because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.". This violation is based on 502(x),801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3896?
According to FDA Import Refusal data, there have been 77 import refusals issued for violation code 3896, affecting 39 unique firms.
When was the most recent refusal for violation 3896?
The most recent import refusal for violation 3896 was on November 1, 2024.
What products are commonly refused for violation 3896?
Products commonly refused under violation 3896 include: STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC), DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC), OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C., MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3896?
Violation code 3896 is based on 502(x),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.