ImportRefusal LogoImportRefusal

Violation Code: 280

FDA Violation

Charge Code: UNSAFE SUB

80
Total Refusals
54
Affected Firms
10/22/2024
Latest Case
1/7/2002
First Case

Violation Details

Violation Code (ASC ID)
280
Charge Code
UNSAFE SUB
Description
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
Legal Section
402(a)(2)(A), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Kaiser Pharmaceutical Co.Tainan City, TAIWAN7
2Sheng Chang Pharmaceutical Co., LtdTaipei, TAIWAN6
3Hurng Fur Foods Factory Co., Ltd.Taipei, TAIWAN6
4Jl KaretPontianakpontianak, INDONESIA3
5Muhammad Mahdi AkbarPontianakpontianak, INDONESIA3
6Mammos Confectionery Co., Ltd. (aka Mammoth Confectionery)Joongwon, SOUTH KORE3
7TSANG FOOK KEE MEDICINE COMPANYSai Ying Pun, HONG KONG2
8Arsy CVBekasi, INDONESIA2
9Xiamen Traditional Chinese Medicine Co., Ltd.Xiamen, CHINA2
10SuhamahBekasi, INDONESIA2
11DAKLAK HONEY BEE JOINT STOCK COMPANYBuon Ma Thout, VIETNAM1
12Bo Ryung Agriculture & FisheryKyunggi-Do, SOUTH KORE1
13Uai] Trading S.A.Nova Lima, BRAZIL1
14Ferme de la TremblayeLa Boissiere Ecole, FRANCE1
15Jiangyin Tianyi Valve Cores Co. Ltd.Jinhua, CHINA1
16Metarom Canada IncGranby, CANADA1
17Gaoming Medicines Health ProductsGuangdong, CHINA1
18TECNO BOTANICA DE MEXICO SA DE CVMEXICO, MEXICO1
19Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz.Tiszavasvari, HUNGARY1
20Swastik Trading Co.Mumbai, INDIA1

Recent Import Refusals

DateProductFirm
10/22/2024
SAUCES, N.E.C.
37JCI99
Nutri-AsiaPHILIPPINE
8/29/2023
BETEL NUT, SHELLED
23BYT14
10/4/2019
BETEL NUT, SHELLED
23BGT14
Hai MinhVIETNAM
2/5/2019
EEL, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
16XGN45
4/13/2017
PLUM, DRIED OR PASTE
21HGT14
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54YY99
1/4/2016
BANABA (HERBAL & BOTANICALS, NOT TEAS)
54FYT95
TomoINDONESIA
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
Jl KaretINDONESIA
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
Jl KaretINDONESIA
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
Jl KaretINDONESIA
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
SuhamahINDONESIA
1/4/2016
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54Y99
SuhamahINDONESIA
1/4/2016
BANABA (HERBAL & BOTANICALS, NOT TEAS)
54FYY95
Arsy CVINDONESIA

Related Violations

Other violations under the same legal section: 402(a)(2)(A), 801(a)(3); ADULTERATION

CodeCharge CodeCases
154FLUOROCARB11

Frequently Asked Questions

What is FDA violation code 280?

280 is an FDA violation code that indicates: "The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.". This violation is based on 402(a)(2)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 280?

According to FDA Import Refusal data, there have been 80 import refusals issued for violation code 280, affecting 54 unique firms.

When was the most recent refusal for violation 280?

The most recent import refusal for violation 280 was on October 22, 2024.

What products are commonly refused for violation 280?

Products commonly refused under violation 280 include: SAUCES, N.E.C., BETEL NUT, SHELLED, EEL, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, PLUM, DRIED OR PASTE. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 280?

Violation code 280 is based on 402(a)(2)(A), 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.