ImportRefusal LogoImportRefusal

Violation Code: 473

FDA Violation

Charge Code: LABELING

13,125
Total Refusals
5141
Affected Firms
1/22/2026
Latest Case
10/5/2001
First Case

Violation Details

Violation Code (ASC ID)
473
Charge Code
LABELING
Description
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Legal Section
Section 4(a); 801(a)(3) Misbranding

Most Affected Firms

#Firm NameLocationCases
1KALINAYekaterinburg, RUSSIA114
2Alnost Guatemala S.AGuatemala, GUATEMALA78
3Rochef ChocolatierGatineau, CANADA72
4Omega Alpha PharmaceuticalsScarborough, CANADA70
5Eveline CosmeticsLesznowola, POLAND67
6COMERCIALIZADORA PEPSICOCiudad De Mexico, MEXICO64
7FarmGroupBarnaul, RUSSIA58
8Gup RtKazan, RUSSIA49
9SinoropaMuriel, GERMANY48
10Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MEXICO48
11UNION MEDICO APSCopenhagen, DENMARK48
12Mammola Funghi Di Bruno RomeoMammola, ITALY40
13Interactive NutritionOttawa, CANADA38
14Cadbury Trebor BassettBirmingham, UNITED KIN37
15Simsek Biskuvi ve gida sanayii A.s.Karaman, TURKEY37
16OMEGA NUTRITIONHidalgo Del Parral, MEXICO35
17PLATINA COSMETICOS LTDAUberaba, BRAZIL35
18Popat Raja & SonsMumbai, INDIA34
19Bescon Co., Ltd.Cheonan-City, SOUTH KORE33
20Ravi Spice Processors Pvt Ltd.Bengaluru, INDIA32

Recent Import Refusals

DateProductFirm
1/22/2026
DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
53IY01
NELSON NATURALS INCCANADA
1/21/2026
CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C.
12YYY99
Mondelez GlobalPHILIPPINE
1/21/2026
CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
33SYY99
GREAT INDIA OVERSEAS PVT LTDINDIA
1/20/2026
CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
33SGT99
Bubs GodisSWEDEN
1/20/2026
CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
33SGT99
Bubs GodisSWEDEN
1/20/2026
CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
33SGT99
Bubs GodisSWEDEN
1/16/2026
BETEL LEAF (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED))
54KBY09
MAE KHEM CO LTDTHAILAND
1/16/2026
CURRY PASTE
37KCN23
MAE KHEM CO LTDTHAILAND
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBA01
Haleon US Holdings LLCUNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBA01
OPMX LLC HEALTHUNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBA01
Akron Pharma, Inc.UNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBH01
Haleon US Holdings LLCUNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBH01
Haleon US Holdings LLCUNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBH01
Haleon US Holdings LLCUNITED STA
1/15/2026
ACETAMINOPHEN (ANALGESIC)
60LBH01
Haleon US Holdings LLCUNITED STA

Frequently Asked Questions

What is FDA violation code 473?

473 is an FDA violation code that indicates: "The article appears in violation of FPLA because of its placement, form and/or contents statement.". This violation is based on Section 4(a); 801(a)(3) Misbranding of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 473?

According to FDA Import Refusal data, there have been 13125 import refusals issued for violation code 473, affecting 5141 unique firms.

When was the most recent refusal for violation 473?

The most recent import refusal for violation 473 was on January 22, 2026.

What products are commonly refused for violation 473?

Products commonly refused under violation 473 include: DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS), CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C., CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 473?

Violation code 473 is based on Section 4(a); 801(a)(3) Misbranding 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.