Violation Code: 3602
FDA Violation
Charge Code: DR PACKGNG
Violation Details
- Violation Code (ASC ID)
- 3602
- Charge Code
- DR PACKGNG
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading
- Legal Section
- 502(i) (1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Kgl Services Express | Abidjan, IVORY COAS | 5 |
| 2 | Tezcom Systems West Africa Limited | Okota Isolo- Lagos, NIGERIA | 2 |
| 3 | Have & Be Co., Ltd. | Gangnam, SOUTH KORE | 2 |
| 4 | AT BIO | Pocheon, SOUTH KORE | 1 |
| 5 | Pharmacia & Upjohn Company LLC | Kalamazoo, UNITED STA | 1 |
| 6 | M/S. SALVI CHEMICAL INDUSTRIES LTD | Mumbai, INDIA | 1 |
| 7 | Cloetta Holland B.V. | Roosendaal, NETHERLAND | 1 |
| 8 | Sviredenko Maria | St Peterburg, RUSSIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 2/7/2023 | FERROUS FUMARATE (HEMATINIC) 64NCR04 | |
| 3/6/2020 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VRY99 | AT BIOSOUTH KORE |
| 4/7/2015 | MENTHOL (ANTI-PRURITIC) 62MBY08 | Cloetta Holland B.V.NETHERLAND |
| 12/29/2014 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99 | |
| 12/29/2014 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99 | |
| 8/19/2014 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LF03 | Have & Be Co., Ltd.SOUTH KORE |
| 8/19/2014 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LF03 | Have & Be Co., Ltd.SOUTH KORE |
| 9/25/2012 | SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) 63RDY05 | Kgl Services ExpressIVORY COAS |
| 9/25/2012 | SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) 63RDY05 | Kgl Services ExpressIVORY COAS |
| 9/25/2012 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IG01 | Kgl Services ExpressIVORY COAS |
| 9/25/2012 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IG01 | Kgl Services ExpressIVORY COAS |
| 9/25/2012 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LD01 | Kgl Services ExpressIVORY COAS |
| 6/21/2012 | DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) 64LAK20 | Pharmacia & Upjohn Company LLCUNITED STA |
| 5/4/2012 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | Sviredenko MariaRUSSIA |
Frequently Asked Questions
What is FDA violation code 3602?
3602 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading". This violation is based on 502(i) (1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3602?
According to FDA Import Refusal data, there have been 14 import refusals issued for violation code 3602, affecting 8 unique firms.
When was the most recent refusal for violation 3602?
The most recent import refusal for violation 3602 was on February 7, 2023.
What products are commonly refused for violation 3602?
Products commonly refused under violation 3602 include: FERROUS FUMARATE (HEMATINIC), MISCELLANEOUS PATENT MEDICINES, ETC., MENTHOL (ANTI-PRURITIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3602?
Violation code 3602 is based on 502(i) (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.