Violation Code: 3908
FDA Violation
Charge Code: 3908
2
Total Refusals
1
Affected Firms
8/26/2024
Latest Case
8/26/2024
First Case
Violation Details
- Violation Code (ASC ID)
- 3908
- Charge Code
- 3908
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | LABORATORIO SANTGAR FORMULAS MAG | Ciudad De Mexico, MEXICO | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/26/2024 | BETAXOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) 62OQY17 | |
| 8/26/2024 | DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) 62OQY26 |
Frequently Asked Questions
What is FDA violation code 3908?
3908 is an FDA violation code used during import inspections.
How many import refusals have been issued for violation 3908?
According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 3908, affecting 1 unique firms.
When was the most recent refusal for violation 3908?
The most recent import refusal for violation 3908 was on August 26, 2024.
What products are commonly refused for violation 3908?
Products commonly refused under violation 3908 include: BETAXOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II), DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II). These products were refused entry because they did not meet FDA requirements.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.