Violation Code: 223
FDA Violation
Charge Code: FALSE
Violation Details
- Violation Code (ASC ID)
- 223
- Charge Code
- FALSE
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
- Legal Section
- 502(a), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Epitomics | Hangzhou, CHINA | 68 |
| 2 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 53 |
| 3 | SHENZHEN DONGJILIAN ELECTRONICS CO., LTD | Shenzhen, CHINA | 36 |
| 4 | LYMA LIFE LTD | London, UNITED KIN | 33 |
| 5 | Holistic Skin Care | Creemore, CANADA | 33 |
| 6 | HERBS FOREVER | Amritsar, INDIA | 24 |
| 7 | Worldgate Vision Beverage Sdn Bhd | Kuala Muda, MALAYSIA | 20 |
| 8 | Belle Mud And Salt Ltd Dead Sea | Arad, ISRAEL | 18 |
| 9 | Escents Aromatherapy | North Vancouver, CANADA | 17 |
| 10 | AGSA GOMMA | San Lazzaro Di Savena, ITALY | 15 |
| 11 | Blue Banyon Ltd | Mold, UNITED KIN | 14 |
| 12 | Solar Cosmetics | Oakville, CANADA | 13 |
| 13 | Cosbel S.A de C.V. | Ciudad De Mexico, MEXICO | 12 |
| 14 | Cosbel, S.A. de C.V. | Mexico, MEXICO | 11 |
| 15 | Encompass Industries Sdn. Bhd. | Kerteh, MALAYSIA | 11 |
| 16 | Homeovitality Company | Preston, UNITED KIN | 10 |
| 17 | SOLOTICA DISTRIBUIDORA DE | Sao Paulo, BRAZIL | 10 |
| 18 | ABCAM | Cambridge, UNITED KIN | 9 |
| 19 | Similasan AG | Jonen, SWITZERLAN | 9 |
| 20 | LYMA LIFE | Swindon, UNITED KIN | 9 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 1/7/2026 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
| 12/10/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 10/27/2025 | FORCEPS 79HTD | Gynamed InstrumentsPAKISTAN |
| 10/27/2025 | FORCEPS 79HTD | Gynamed InstrumentsPAKISTAN |
| 10/23/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCH99 |
Related Violations
Other violations under the same legal section: 502(a), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 223?
223 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.". This violation is based on 502(a), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 223?
According to FDA Import Refusal data, there have been 1649 import refusals issued for violation code 223, affecting 795 unique firms.
When was the most recent refusal for violation 223?
The most recent import refusal for violation 223 was on January 7, 2026.
What products are commonly refused for violation 223?
Products commonly refused under violation 223 include: GLOVE, PATIENT EXAMINATION, POLY. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 223?
Violation code 223 is based on 502(a), 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.