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Violation Code: 3320

FDA Violation

Charge Code: TRANSFAT

1,397
Total Refusals
503
Affected Firms
4/9/2025
Latest Case
12/13/2006
First Case

Violation Details

Violation Code (ASC ID)
3320
Charge Code
TRANSFAT
Description
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
Legal Section
403(q), 801(a)(3) ;MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Cadbury Trebor BassettBirmingham, UNITED KIN86
2Chokoladespecialisten Kbh A/STaastrup, DENMARK53
3Nestle Food ServiceYork, UNITED KIN31
4Maestri Pasta/G.A.C. SrlMercato San Severino, ITALY24
5Burton Foods LimitedBlackpool, UNITED KIN23
6PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY TbkBandung, INDONESIA20
7Turner and Wrights LtdBolton, UNITED KIN19
8Al Suhagy For Food IndustriesKalubia Cairo, EGYPT19
9Mars Confectionery Div Of Mars UK LtdSlough, UNITED KIN17
10English Biscuit Manufacturers (Pvt.) Ltd.Karachi, PAKISTAN17
11Ushodaya Enterprises Pvt. Ltd., (Foods Division), Poranki.Poranki, INDIA17
12NisaWay / Bibby DistributionScunthorpe, UNITED KIN17
13Premiere Intl CorpLondon, UNITED KIN16
14H J Heinz Co LtdHayes, UNITED KIN16
15OOO RUSEXPORTSankt-Peterburg, RUSSIA15
16Centura FoodEgham, UNITED KIN15
17ABDEL REHIMABDEL HAFEZAlexandria, EGYPT14
18Azienda Agricola Erga Bio di Damiano ErmicidaBadolato, ITALY12
19ITN FoodToronto, CANADA11
20Produits Achtaroute IncMontreal, CANADA10

Recent Import Refusals

DateProductFirm
4/9/2025
MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
28EGT99
KAMENA PRODUCTS CORPORATIONEGYPT
2/20/2025
MIXED PLAIN COOKIES,BISCUITS AND WAFERS
03HGT07
XPORTAGT, S.A.GUATEMALA
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
1/22/2025
CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT02
Lotte Wellfood Co., Ltd. (Yangsan Factory)SOUTH KORE
8/21/2024
VIRGIN OLIVE OIL, CRUDE
26AET09
FEDERATA BUJQESORE ELBASANALBANIA
5/1/2024
SOY SAUCE
37JGT05
SAN-J INTERNATIONALUNITED STA
4/15/2024
NOODLES AND NOODLE PRODUCTS, N.E.C.
04CGT99
Nestle India LimitedINDIA
5/23/2022
CHOCOLATE AND COCOA PRODUCTS, N.E.C.
34YYT99
Confiserie Sprungli AGSWITZERLAN
12/21/2021
OTHER FRUITS, MIXED FRUIT PUREES
21FYT09
Potentia Trium B.VNETHERLAND
6/8/2021
VITAMIN, N.E.C.
54AYY99
HESHAM MANSOOR TRADINGMALAYSIA
11/4/2020
BEAN CURD, FRESH - SOFT OR HARD (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS)
37BGN27
Ourhome Ltd.SOUTH KORE

Frequently Asked Questions

What is FDA violation code 3320?

3320 is an FDA violation code that indicates: "The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].". This violation is based on 403(q), 801(a)(3) ;MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3320?

According to FDA Import Refusal data, there have been 1397 import refusals issued for violation code 3320, affecting 503 unique firms.

When was the most recent refusal for violation 3320?

The most recent import refusal for violation 3320 was on April 9, 2025.

What products are commonly refused for violation 3320?

Products commonly refused under violation 3320 include: MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C., MIXED PLAIN COOKIES,BISCUITS AND WAFERS, CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3320?

Violation code 3320 is based on 403(q), 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.