Violation Code: 2060
FDA Violation
Charge Code: AGRINSULIN
Violation Details
- Violation Code (ASC ID)
- 2060
- Charge Code
- AGRINSULIN
- Description
- The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
- Legal Section
- 801(d)(1),(2);IMPORTATION RESTRICTED
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Novo Nordisk Pharmaceuticals | Crawley, UNITED KIN | 9 |
| 2 | Lilly Usa, Llc. | Indianapolis, UNITED STA | 3 |
| 3 | Ups Tsg | Lachine, CANADA | 2 |
| 4 | Eli Lilly & Company | Indianapolis, UNITED STA | 2 |
| 5 | Sanofi Canada | Laval, CANADA | 1 |
| 6 | Nan Drawie Lau | Markham, CANADA | 1 |
| 7 | Southern Skies | Lachine, CANADA | 1 |
| 8 | Mitcham & Benjamin | Basseterre, SAINT KITT | 1 |
| 9 | Clinical Research Pharmacy | Sasco, DENMARK | 1 |
| 10 | Ial Engineering Services Ltc | San Fernando, TRINIDAD A | 1 |
| 11 | The Exchange Tower | Toronto, CANADA | 1 |
| 12 | Holland America Line - | Seattle, UNITED STA | 1 |
| 13 | ELI LILLY CANADA INC | Toronto, CANADA | 1 |
| 14 | Covidien LP | Mansfield, UNITED STA | 1 |
| 15 | Sanofi US Services, Inc. | Morristown, UNITED STA | 1 |
| 16 | Novo Nordisk Inc. | Plainsboro, UNITED STA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/21/2025 | INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) 61PCY58 | ELI LILLY CANADA INCCANADA |
| 1/21/2025 | INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) 61PCY58 | The Exchange TowerCANADA |
| 11/22/2023 | INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) 61PCY58 | Sanofi CanadaCANADA |
| 1/11/2017 | INSULIN (INJ) (ANTI-DIABETIC) 61PCK17 | Eli Lilly & CompanyUNITED STA |
| 12/1/2014 | INSULIN (INJ) (ANTI-DIABETIC) 61PCK17 | Novo Nordisk Inc.UNITED STA |
| 4/4/2014 | INSULIN (INJ) (ANTI-DIABETIC) 61P17 | Lilly Usa, Llc.UNITED STA |
| 4/4/2014 | INSULIN (INJ) (ANTI-DIABETIC) 61P17 | Lilly Usa, Llc.UNITED STA |
| 4/4/2014 | INSULIN (INJ) (ANTI-DIABETIC) 61P17 | Lilly Usa, Llc.UNITED STA |
| 5/20/2013 | INSULIN (INJ) (ANTI-DIABETIC) 61PCY17 | Eli Lilly & CompanyUNITED STA |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
| 12/14/2012 | INSULIN (INJ) (ANTI-DIABETIC) 61PDL17 | Novo Nordisk PharmaceuticalsUNITED KIN |
Frequently Asked Questions
What is FDA violation code 2060?
2060 is an FDA violation code that indicates: "The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for 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 2060?
According to FDA Import Refusal data, there have been 28 import refusals issued for violation code 2060, affecting 16 unique firms.
When was the most recent refusal for violation 2060?
The most recent import refusal for violation 2060 was on January 21, 2025.
What products are commonly refused for violation 2060?
Products commonly refused under violation 2060 include: INSULIN LISPRO PROTAMINE (ANTI-DIABETIC), INSULIN (INJ) (ANTI-DIABETIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2060?
Violation code 2060 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.