Violation Code: 3340
FDA Violation
Charge Code: DE/RX KIT
Violation Details
- Violation Code (ASC ID)
- 3340
- Charge Code
- DE/RX KIT
- Description
- The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
- Legal Section
- 801(d)(1),(2); IMPORTATION RESTRICTED
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Bard Reynosa S.A. De C.V. | Reynosa, MEXICO | 14 |
| 2 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 8 |
| 3 | Tri State De Mexico | Mexicali, MEXICO | 6 |
| 4 | P Krishnamurthy | Bangalore, INDIA | 5 |
| 5 | ICU Medical, Inc. | Lake Forest, UNITED STA | 4 |
| 6 | Medique Products | Fort Myers, UNITED STA | 3 |
| 7 | Becton Dickinson & Company | Franklin Lakes, UNITED STA | 3 |
| 8 | Medline Industries, LP | Mundelein, UNITED STA | 2 |
| 9 | Covidien | Tijuana, MEXICO | 2 |
| 10 | DMS Holdings, Inc. dba HealthSmart | Waukegan, UNITED STA | 2 |
| 11 | Jml Direct America Llc | London, UNITED KIN | 2 |
| 12 | DSHealthcare Inc. dba Sultan Health Care | Hackensack, UNITED STA | 2 |
| 13 | MERK MEXICO SA | NAUCULPCIN, MEXICO | 2 |
| 14 | International Medication Systems Ltd. | South El Monte, UNITED STA | 2 |
| 15 | Hospira, Inc. | Lake Forest, UNITED STA | 1 |
| 16 | Carnot Laboratorios | Mexico, MEXICO | 1 |
| 17 | Terzo Sandro | Roma, ITALY | 1 |
| 18 | Vista Pharm | Birmingham, UNITED STA | 1 |
| 19 | Sanofi-Aventis De Mexico | Ocoyoacac, MEXICO | 1 |
| 20 | Genesis II Church of Health and Healing | Unknown, IRELAND | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 2/24/2022 | LISINOPRIL (ANTI-HYPERTENSIVE) 62CDB65 | Lupin Pharmaceuticals Inc.UNITED STA |
| 4/21/2021 | ANTI-ANEMIC, N.E.C. 61CDA99 | MERCK BIOPHARMAMEXICO |
| 4/21/2021 | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) 62GDA18 | MERK MEXICO SAMEXICO |
| 4/21/2021 | ANTI-ANEMIC, N.E.C. 61CDA99 | MERK MEXICO SAMEXICO |
| 4/21/2021 | ANTI-ANEMIC, N.E.C. 61CDA99 | Sanofi-Aventis De MexicoMEXICO |
| 4/21/2021 | CYPROHEPTADINE HCL (ANTI-HISTAMINIC) 61XDA14 | Carnot LaboratoriosMEXICO |
| 4/12/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 8/26/2020 | HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) 62UBY13 | |
| 9/10/2018 | LIDOCAINE 60QCP07 | Hospira, Inc.UNITED STA |
| 2/12/2016 | ESTROGEN N.E.C. 64GCD99 | Noven Pharmaceuticals IncUNITED STA |
| 2/5/2016 | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY 77OSM | Jml Direct America LlcUNITED KIN |
| 2/5/2016 | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY 77OSM | Jml Direct America LlcUNITED KIN |
| 10/1/2015 | INTRODUCER, SYRINGE NEEDLE 80KZH | Becton Dickinson & CompanyUNITED STA |
| 10/1/2015 | SYRINGE, ANTISTICK 80MEG | Becton Dickinson & CompanyUNITED STA |
| 10/1/2015 | SYRINGE, ANTISTICK 80MEG | Becton Dickinson & CompanyUNITED STA |
Related Violations
Other violations under the same legal section: 801(d)(1),(2); IMPORTATION RESTRICTED
Frequently Asked Questions
What is FDA violation code 3340?
3340 is an FDA violation code that indicates: "The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.". This violation is based on 801(d)(1),(2); IMPORTATION RESTRICTED of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3340?
According to FDA Import Refusal data, there have been 79 import refusals issued for violation code 3340, affecting 36 unique firms.
When was the most recent refusal for violation 3340?
The most recent import refusal for violation 3340 was on February 24, 2022.
What products are commonly refused for violation 3340?
Products commonly refused under violation 3340 include: LISINOPRIL (ANTI-HYPERTENSIVE), ANTI-ANEMIC, N.E.C., DICLOFENAC SODIUM (ANTI-INFLAMMATORY). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3340?
Violation code 3340 is based on 801(d)(1),(2); IMPORTATION RESTRICTED 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.