Violation Code: 55
FDA Violation
Charge Code: OMITTED
Violation Details
- Violation Code (ASC ID)
- 55
- Charge Code
- OMITTED
- Description
- The article is subject to refusal of admission pursuant Section 801(a)(3) of the FD&C Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article.
- Legal Section
- 402(b)(1), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/2/2024 | SAFFRON, NATURAL EXTRACT OR FLAVOR (SPICE) 28CYT40 | |
| 7/9/2024 | SAFFRON, GROUND, CRACKED (SPICE) 28BET40 | |
| 7/8/2024 | SAFFRON, NATURAL EXTRACT OR FLAVOR (SPICE) 28CYY40 | |
| 6/10/2024 | SAFFRON, WHOLE (SPICE) 28AYY40 | |
| 6/10/2024 | SAFFRON, WHOLE (SPICE) 28AET40 | |
| 5/31/2024 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54ACL90 | Laboratorios Combisa S.A. de C.V.EL SALVADO |
| 5/8/2024 | SAFFRON, WHOLE (SPICE) 28AGY40 | |
| 4/3/2024 | SAFFRON, WHOLE (SPICE) 28AET40 | |
| 4/3/2024 | SAFFRON, WHOLE (SPICE) 28AGT40 | |
| 4/3/2024 | SAFFRON, WHOLE (SPICE) 28AGT40 | |
| 4/3/2024 | SAFFRON, WHOLE (SPICE) 28AGT40 | |
| 12/12/2023 | SAFFRON, WHOLE (SPICE) 28AEH40 | Luis Penalva, S.L.SPAIN |
| 12/12/2023 | SAFFRON, WHOLE (SPICE) 28AEH40 | Luis Penalva, S.L.SPAIN |
| 12/12/2023 | SAFFRON, WHOLE (SPICE) 28AFH40 | Luis Penalva, S.L.SPAIN |
| 12/11/2023 | SAFFRON, WHOLE (SPICE) 28AET40 |
Frequently Asked Questions
What is FDA violation code 55?
55 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant Section 801(a)(3) of the FD&C Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article.". This violation is based on 402(b)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 55?
According to FDA Import Refusal data, there have been 83 import refusals issued for violation code 55, affecting 28 unique firms.
When was the most recent refusal for violation 55?
The most recent import refusal for violation 55 was on October 2, 2024.
What products are commonly refused for violation 55?
Products commonly refused under violation 55 include: SAFFRON, NATURAL EXTRACT OR FLAVOR (SPICE), SAFFRON, GROUND, CRACKED (SPICE), SAFFRON, WHOLE (SPICE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 55?
Violation code 55 is based on 402(b)(1), 801(a)(3); ADULTERATION 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.