Violation Code: 336
FDA Violation
Charge Code: INCONSPICU
Violation Details
- Violation Code (ASC ID)
- 336
- Charge Code
- INCONSPICU
- Description
- Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
- Legal Section
- 502(c), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 75 |
| 2 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 40 |
| 3 | Church & Dwight Co., Inc. | Lakewood, UNITED STA | 31 |
| 4 | Frabel Sa De Cv | Ciudad De Mexico, MEXICO | 27 |
| 5 | Cosbel S.A de C.V. | Ciudad De Mexico, MEXICO | 26 |
| 6 | BRITISH VITATECH | Leicester, UNITED KIN | 23 |
| 7 | FUKUWARAKU COMPANY LTD | Osaka, JAPAN | 23 |
| 8 | TECNO INSTRUMENTS (PVT.) LTD. | Sialkot, PAKISTAN | 22 |
| 9 | The Procter & Gamble Company | Cincinnati, UNITED STA | 21 |
| 10 | DCS EXPORT | Banbury, UNITED KIN | 20 |
| 11 | U N D A | Brussel, BELGIUM | 20 |
| 12 | Wenzhou Shengkai Technology Industry Co., Ltd. | Wenzhou, CHINA | 15 |
| 13 | Laboratorium Soluna Heilmittel Gmbh | Donauworth, GERMANY | 15 |
| 14 | Les Importations Herbasante Inc. | Saint-Laurent, CANADA | 13 |
| 15 | Cipla Limited | Salcette, INDIA | 13 |
| 16 | Indusrial Clothings Limited | Colombo, SRI LANKA | 11 |
| 17 | Medisca Pharmaceutique Inc. | Saint-Laurent, CANADA | 10 |
| 18 | TIS SANAYI DIS TICARET AS | Istanbul, TURKEY | 10 |
| 19 | Unilever Mexico S de R.L. de C.V. | Jiutepec, MEXICO | 9 |
| 20 | Wenzhou Xinke Electric Co. Ltd | Wenzhou, CHINA | 9 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/25/2025 | PEPTIDE N.E.C. 56FYY99 | BOLISE CO LIMITEDCHINA |
| 11/21/2025 | OMALIZUMAB 58ACP04 | Novartis Pharma GmbhGERMANY |
| 11/14/2025 | SYRINGE, PISTON 80FMF | ELI LILLY CANADA INCCANADA |
| 10/31/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIY99 | ALLERS GROUPCOLOMBIA |
| 10/29/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | KdermaSOUTH KORE |
| 10/29/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Exocobio, Inc.SOUTH KORE |
| 10/24/2025 | BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) 29RHT04 | |
| 10/24/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29AHT99 | |
| 10/9/2025 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YBY99 | |
| 10/9/2025 | SYRINGE, PISTON 80FMF | |
| 10/9/2025 | PEPTIDE N.E.C. 56FAY99 | |
| 10/3/2025 | STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RBY06 | HALEONCANADA |
| 10/3/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBU17 | Revlon Group Holdings, LLCUNITED STA |
| 10/3/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBU17 | Revlon Group Holdings, LLCUNITED STA |
| 9/4/2025 | MIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITH NUTS OR NUT PRODUCTS (NOT COCONU 34CMT07 |
Related Violations
Other violations under the same legal section: 502(c), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 3883 | 708NODFL | 21 |
Frequently Asked Questions
What is FDA violation code 336?
336 is an FDA violation code that indicates: "Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.". This violation is based on 502(c), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 336?
According to FDA Import Refusal data, there have been 1662 import refusals issued for violation code 336, affecting 838 unique firms.
When was the most recent refusal for violation 336?
The most recent import refusal for violation 336 was on November 25, 2025.
What products are commonly refused for violation 336?
Products commonly refused under violation 336 include: PEPTIDE N.E.C., OMALIZUMAB, SYRINGE, PISTON, MISCELLANEOUS PATENT MEDICINES, ETC., 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 336?
Violation code 336 is based on 502(c), 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.