Violation Code: 75
FDA Violation
Charge Code: UNAPPROVED
Violation Details
- Violation Code (ASC ID)
- 75
- Charge Code
- UNAPPROVED
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
- Legal Section
- 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Wicks Pharmaceuticals Pvt Ltd | Bangalore, INDIA | 576 |
| 2 | DREAM COSMETICS | Abigian, IVORY COAS | 415 |
| 3 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 379 |
| 4 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 311 |
| 5 | NOVO NORDISK | Mississauga, CANADA | 197 |
| 6 | Sanofi-Aventis US LLC | Saint Louis, UNITED STA | 196 |
| 7 | A.H. GEIGER | Lorrach, GERMANY | 177 |
| 8 | Novo Nordisk A/S | Bagsvard, DENMARK | 172 |
| 9 | Chemo S.A. Lugano Branch | Lugano, SWITZERLAN | 171 |
| 10 | PLANTAS MEDICINALES DE MEXICO | DELEGACION XOCHIMILCO C.P, MEXICO | 169 |
| 11 | PATANJALI AYURVED LIMITED | Haridwar, INDIA | 169 |
| 12 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 154 |
| 13 | Wendt-Chemie Vertriebsges Mbh & Co. | Hamburg, GERMANY | 151 |
| 14 | Productos Maver, S.A. de C.V. | Tlaquepaque, MEXICO | 146 |
| 15 | Merck, S.A. de C.V. | Naucalpan De Juarez, MEXICO | 137 |
| 16 | SKYLINE HANDELS GMBH | Vienna, AUSTRIA | 135 |
| 17 | Apotex Inc. | North York, CANADA | 128 |
| 18 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 127 |
| 19 | Terravita | Brampton, CANADA | 119 |
| 20 | Biologische Heilmittel Heel Gmbh | Baden-Baden, GERMANY | 118 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LD99 | Cosmax IncSOUTH KORE |
| 1/22/2026 | ONABOTULINUMTOXINA 58PCZ05 | Merz Pharma GmbH & Co., KGaAGERMANY |
| 1/22/2026 | SODIUM CHLORIDE (REPLENISHER) 65RCK19 | FRESENIUS KABI BIDIPHAR JSCVIETNAM |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YCY99 | WWW.R3JUVEN8.ETAUSTRALIA |
| 1/22/2026 | VITAMIN, N.E.C. 54ACK99 | NATURAL MEDY DISTRIBUCIONES SASCOLOMBIA |
| 1/22/2026 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | BC LTD C/O PASTURESINGAPORE |
| 1/22/2026 | ADALIMUMAB 58SCY14 | Abbvie Biotechnology GmbhGERMANY |
| 1/22/2026 | CAMPHOR (ANTI-PRURITIC) 62MDY01 | |
| 1/22/2026 | METHYLPREDNISOLONE (GLUCOCORTICOID) 64LDY44 | |
| 1/22/2026 | THEOPHYLLINE (BRONCHODILATOR) 63BDY30 | |
| 1/22/2026 | ACETAMINOPHEN (ANALGESIC) 60LDY01 | |
| 1/22/2026 | AZITHROMYCIN (MACAROLIDES) 56IDY76 | |
| 1/22/2026 | ALBUTEROL (BRONCHODILATOR) 63BDY01 | Cipla Pvt LtdINDIA |
| 1/22/2026 | DAPAGLIFLOZIN (ANTI-DIABETIC) 61PDY70 | AstraZeneca Pharmaceuticals LPUNITED STA |
| 1/22/2026 | SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) 61PDY68 |
Related Violations
Other violations under the same legal section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG
| Code | Charge Code | Cases |
|---|---|---|
| 3874 | 708NEWDRUG | 5 |
Frequently Asked Questions
What is FDA violation code 75?
75 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).". This violation is based on 505(a), 801(a)(3); UNAPPROVED NEW DRUG of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 75?
According to FDA Import Refusal data, there have been 74390 import refusals issued for violation code 75, affecting 26301 unique firms.
When was the most recent refusal for violation 75?
The most recent import refusal for violation 75 was on January 22, 2026.
What products are commonly refused for violation 75?
Products commonly refused under violation 75 include: OTHER SKIN CARE PREPARATIONS, N.E.C., ONABOTULINUMTOXINA, SODIUM CHLORIDE (REPLENISHER), EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C., VITAMIN, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 75?
Violation code 75 is based on 505(a), 801(a)(3); UNAPPROVED NEW DRUG 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.