Violation Code: 333
FDA Violation
Charge Code: LACKS FIRM
Violation Details
- Violation Code (ASC ID)
- 333
- Charge Code
- LACKS FIRM
- Description
- The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
- Legal Section
- 502(b)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Best-pharm Ltd. | Moscow, RUSSIA | 92 |
| 2 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 37 |
| 3 | Comercial Artesana Sosa | Barcelona, SPAIN | 25 |
| 4 | Farmacia Homeopathica Vida | Zapopan, MEXICO | 22 |
| 5 | TECNO INSTRUMENTS (PVT.) LTD. | Sialkot, PAKISTAN | 22 |
| 6 | CARBON COCO | Thomastown, AUSTRALIA | 22 |
| 7 | Macrovita | Nea Philadelphia, GREECE | 18 |
| 8 | DCS EXPORT | Banbury, UNITED KIN | 17 |
| 9 | Wenzhou Shengkai Technology Industry Co., Ltd. | Wenzhou, CHINA | 15 |
| 10 | Korolevfarm | Korolev, RUSSIA | 14 |
| 11 | UNIVERSAL FINANCIAL GROUP LTD | Riga, LATVIA | 14 |
| 12 | Fu Sung Pharmaceutaical Works | Unknown, CHINA | 14 |
| 13 | Ophtapharm AG | Winterthur, SWITZERLAN | 12 |
| 14 | Sinoropa | Muriel, GERMANY | 11 |
| 15 | NEFTIS LABORATORIOS SL | Santa Eulalia de Ron��ana, SPAIN | 10 |
| 16 | IND Diagnostic Inc. | Delta, CANADA | 9 |
| 17 | Wenzhou Xinke Electric Co. Ltd | Wenzhou, CHINA | 9 |
| 18 | ADI INDUSTRY CO LIMITED | Kowloon Bay, HONG KONG | 9 |
| 19 | Lovetoys Industrial Co Ltd | Nancheng, CHINA | 8 |
| 20 | Uniqso Holdings Sdn Bhd | Cheras, MALAYSIA | 8 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/1/2025 | TIRZEPATIDE (ANTI-DIABETIC) 61PJL74 | Unknown US ManufacturerUNITED STA |
| 11/26/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Laytec In-Line GmbhGERMANY |
| 11/25/2025 | PEPTIDE N.E.C. 56FYY99 | BOLISE CO LIMITEDCHINA |
| 11/13/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | DUKSAN PURE CHEMICALS CO., LTD.SOUTH KORE |
| 11/12/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBR99 | HOA NAM PHARMAVIETNAM |
| 11/10/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Sanofi AventisFRANCE |
| 11/6/2025 | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT 79MDA | |
| 10/23/2025 | SALICYLIC ACID (KERATOLYTIC) 64XBY06 | GUANGZHOU PALLAS COSMETICS CO.,HONG KONG |
| 10/21/2025 | LASER THERAPY PRODUCT 95RHL | |
| 10/7/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 9/22/2025 | MINOXIDIL (ANTI-HYPERTENSIVE) 62CIL41 | |
| 8/26/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBK99 | GUAN YU CO., LIMITEDHONG KONG |
| 8/26/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCZ99 | GUAN YU CO., LIMITEDHONG KONG |
| 8/25/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | TUNAS MANJAMALAYSIA |
| 8/11/2025 | CANNULA, CATHETER 74DQR |
Related Violations
Other violations under the same legal section: 502(b)(1), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 3869 | 708LBLFIRM | 1 |
Frequently Asked Questions
What is FDA violation code 333?
333 is an FDA violation code that indicates: "The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.". This violation is based on 502(b)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 333?
According to FDA Import Refusal data, there have been 2373 import refusals issued for violation code 333, affecting 1419 unique firms.
When was the most recent refusal for violation 333?
The most recent import refusal for violation 333 was on December 1, 2025.
What products are commonly refused for violation 333?
Products commonly refused under violation 333 include: TIRZEPATIDE (ANTI-DIABETIC), GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL, PEPTIDE N.E.C., MISCELLANEOUS PATENT MEDICINES, ETC.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 333?
Violation code 333 is based on 502(b)(1), 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.