Violation Code: 344
FDA Violation
Charge Code: WARNINGS
Violation Details
- Violation Code (ASC ID)
- 344
- Charge Code
- WARNINGS
- Description
- It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
- Legal Section
- 502(f)(2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 17 |
| 2 | Bie-Dro C. Nuyken Kg | Bielefeld, GERMANY | 9 |
| 3 | Pax-All Manufacturing Inc | Lasalle, CANADA | 8 |
| 4 | LEADS (CHINA) BIOTECH CO LTD | Zhangzhou, CHINA | 6 |
| 5 | Meditime Co Ltd | Yong-in, SOUTH KORE | 6 |
| 6 | Nanjing Joymain | Nanjing, CHINA | 5 |
| 7 | Enviro Fresh Products | North York, CANADA | 5 |
| 8 | CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD. | Chengdu, CHINA | 5 |
| 9 | CMI Cosmetic Manufacturers Inc. | Concord, CANADA | 4 |
| 10 | Centro Botanico Plantimex, S.A. De C.V. | D.F, MEXICO | 4 |
| 11 | Dr Irena Eris S.A. | Piaseczno, POLAND | 4 |
| 12 | Reckitt Benckiser (UK) Ltd. | Hull, UNITED KIN | 4 |
| 13 | Zhejiang Materials Chemical and Light Industry Co ltd | Hangzhou, CHINA | 4 |
| 14 | Colgate-Palmolive Cda | Toronto, CANADA | 4 |
| 15 | Khang Health Products Ltd | Richmond Hill, CANADA | 4 |
| 16 | Revlon Intl Inc | New York, UNITED STA | 4 |
| 17 | Eau Zone Huiles & Fragrances Lee | Montreal, CANADA | 4 |
| 18 | Oui Pack | Bois De Filion, CANADA | 3 |
| 19 | Shanghai Hutchison Whitecat Co., Ltd. | Shanghai, CHINA | 3 |
| 20 | 2plus Electronic I | Zhongshan Cit, CHINA | 3 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/12/2026 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIZ99 | |
| 7/21/2025 | METHYLTESTOSTERONE (ANDROGEN) 60NIA04 | |
| 5/30/2025 | TOOTHBRUSH, MANUAL 76EFW | |
| 5/9/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Allergan Industrie SASFRANCE |
| 3/4/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | REVITACAREFRANCE |
| 3/4/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | REVITACAREFRANCE |
| 3/4/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 3/4/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | REVITACAREFRANCE |
| 2/27/2025 | INJECTOR, PEN 80NSC | |
| 2/27/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | INFNI LABITALY |
| 2/27/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | INFNI LABITALY |
| 2/25/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 12/9/2024 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDK99 | |
| 7/1/2024 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIP99 | GMSSOUTH KORE |
| 6/17/2024 | LASER ILLUMINATED LIGHTING INSTRUMENT 95RIN |
Frequently Asked Questions
What is FDA violation code 344?
344 is an FDA violation code that indicates: "It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.". This violation is based on 502(f)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 344?
According to FDA Import Refusal data, there have been 420 import refusals issued for violation code 344, affecting 272 unique firms.
When was the most recent refusal for violation 344?
The most recent import refusal for violation 344 was on January 12, 2026.
What products are commonly refused for violation 344?
Products commonly refused under violation 344 include: MISCELLANEOUS PATENT MEDICINES, ETC., METHYLTESTOSTERONE (ANDROGEN), TOOTHBRUSH, MANUAL, IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 344?
Violation code 344 is based on 502(f)(2), 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.