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Violation Code: 55

FDA Violation

Charge Code: OMITTED

84
Total Refusals
29
Affected Firms
1/12/2026
Latest Case
10/15/2002
First Case

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

#Firm NameLocationCases
1Mars Pet Care-Lebanon SIteLebanon, UNITED STA27
2The Harvest Of Saffron, S.L.La Solana, SPAIN11
3SHS International, Ltd. dba Nutricia LiverpoolLiverpool, UNITED KIN8
4VERDU CANTO SAFFRON SPAIN, S.L.Novelda, SPAIN6
5Luis Penalva, S.L.Novelda, SPAIN3
6Goknur Gida Maddeleri Enerji Imalat Ithalat Ihracat Tic. ve San. A.S.Nigde, TURKEY3
7Meybuz Gida Enerji Sanayi Ve Ticaret A.S.Ankara, TURKEY2
8Pasta Combattenti SpaCorte De' Frati, ITALY2
9Antonio Garcia Inesta SLNovelda, SPAIN2
10L. Dometita & Sons Food IndustriesQuezon City, PHILIPPINE1
11MANUEL ROMERO DE AVILA RAMIREZAlbacete, SPAIN1
12Agroindustrias AIBLima, PERU1
13Multifoods S.A.C.Lima, PERU1
14PT Tripper NatureBekasi, INDONESIA1
15Se-cure Pharmaceuticals LtdDalton, ISRAEL1
16Talay Sorkh Afghan LtdHerat, AFGHANISTA1
17TANG MINH IMP. & EXP. TRADING CO.LTDDong Nai, VIETNAM1
18Thorne ResearchSurrey, CANADA1
19Tianjin Foodstuffs Imp & Exp CorpTianjin, CHINA1
20Triselecta S.LTorremolinos, SPAIN1

Recent Import Refusals

DateProductFirm
1/12/2026
CLOVE, GROUND, CRACKED (SPICE)
28BGT14
PT Tripper NatureINDONESIA
10/2/2024
SAFFRON, NATURAL EXTRACT OR FLAVOR (SPICE)
28CYT40
Manuel Romero De Avila Ramirez S.A.SPAIN
7/9/2024
SAFFRON, GROUND, CRACKED (SPICE)
28BET40
The Harvest Of Saffron, S.L.SPAIN
7/8/2024
SAFFRON, NATURAL EXTRACT OR FLAVOR (SPICE)
28CYY40
The Harvest Of Saffron, S.L.SPAIN
6/10/2024
SAFFRON, WHOLE (SPICE)
28AYY40
The Harvest Of Saffron, S.L.SPAIN
6/10/2024
SAFFRON, WHOLE (SPICE)
28AET40
MANUEL ROMERO DE AVILA RAMIREZSPAIN
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
VERDU CANTO SAFFRON SPAIN, S.L.SPAIN
4/3/2024
SAFFRON, WHOLE (SPICE)
28AET40
The Harvest Of Saffron, S.L.SPAIN
4/3/2024
SAFFRON, WHOLE (SPICE)
28AGT40
The Harvest Of Saffron, S.L.SPAIN
4/3/2024
SAFFRON, WHOLE (SPICE)
28AGT40
The Harvest Of Saffron, S.L.SPAIN
4/3/2024
SAFFRON, WHOLE (SPICE)
28AGT40
The Harvest Of Saffron, S.L.SPAIN
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

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 84 import refusals issued for violation code 55, affecting 29 unique firms.

When was the most recent refusal for violation 55?

The most recent import refusal for violation 55 was on January 12, 2026.

What products are commonly refused for violation 55?

Products commonly refused under violation 55 include: CLOVE, GROUND, CRACKED (SPICE), 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.