ImportRefusal LogoImportRefusal

Violation Code: 117

FDA Violation

Charge Code: DANGEROUS

221
Total Refusals
74
Affected Firms
11/20/2025
Latest Case
12/7/2001
First Case

Violation Details

Violation Code (ASC ID)
117
Charge Code
DANGEROUS
Description
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
Legal Section
502(j), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Genesis II Church of Health and HealingUnknown, IRELAND88
2Kaiser Pharmaceutical Co.Tainan City, TAIWAN18
3Blue Banyon LtdMold, UNITED KIN15
4Laboratorios Contifarma, C. Por A.Santa Domingo, DOMINICAN 9
5Allmed Medical Products Co Ltd. (Shenzen Factory)Shenzen, CHINA8
6E.D.I.T. Ltd.Middlesex, UNITED KIN5
7Daxal Cosmetics Pvt. Ltd.Ahmedabad, INDIA3
8Sa Post Office - XpsJetparkjetpark, SOUTH AFRI3
9Nanjing Chemlin Biomedical Science & Technology Co, Ltd.Nanjing, CHINA2
10Planet Earth LogisticsWakefield, UNITED KIN2
11Sesderma, SLRafelbunol, SPAIN2
12UnknownUnknown, RUSSIA2
13Dr Srinivas Chiluveruprofessor MateriamedicaHyderabad, INDIA2
14BoironMessimy, FRANCE2
15Ethicon Endo-Surgery SA de CV, Planta IIJuarez, MEXICO1
16Crystal Field LtdSha Tin, HONG KONG1
17Mikwang Contact Lens Co LtdKyungsangdo, SOUTH KORE1
18Jiangsu Nanfang Medical Co., Ltd.Changzhou, CHINA1
19Bayer Healthcare Pharmaceuticals Inc.Whippany, UNITED STA1
20Versele-Laga nvDeinze, BELGIUM1

Recent Import Refusals

DateProductFirm
11/20/2025
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
IBSA Farmaceutici Italia SrlITALY
5/30/2025
TOOTHBRUSH, MANUAL
76EFW
YANGZHOU CLAIRO SCIENCE AND TECHNOLOGY CO.,LTDCHINA
12/5/2024
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
Sesderma, SLSPAIN
12/5/2024
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
Sesderma, SLSPAIN
11/13/2023
PERCUSSOR, POWERED-ELECTRIC
73BYI
Better Breathing Devices Pty LtdAUSTRALIA
4/5/2022
RESERPINE (ANTI-HYPERTENSIVE)
62CQT51
Nanjing Chemlin Biomedical Science & Technology Co, Ltd.CHINA
4/5/2022
RESERPINE (ANTI-HYPERTENSIVE)
62CQT51
Nanjing Chemlin Biomedical Science & Technology Co, Ltd.CHINA
10/14/2021
MISCELLANEOUS PATENT MEDICINES, ETC.
66VDY99
Laboratorios Roldan S.A.DOMINICAN
12/31/2020
ETHYL ALCOHOL (ANTI-MICROBIAL)
62HBL05
AriBio H&BSOUTH KORE
11/13/2019
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBG04
Daxal Cosmetics Pvt. Ltd.INDIA
11/13/2019
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBG04
Daxal Cosmetics Pvt. Ltd.INDIA
11/13/2019
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBG04
Daxal Cosmetics Pvt. Ltd.INDIA
6/26/2017
LENSES, SOFT CONTACT, DAILY WEAR
86LPL
SOLOTICA DISTRIBUIDORA DEBRAZIL
8/25/2016
SYSTEM, LASER, PHOTODYNAMIC THERAPY
79MVF
DANYANG JIECHENG ELECTRONICS CO.CHINA
5/23/2016
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
79GAT
Ethicon Endo-Surgery SA de CV, Planta IIMEXICO

Frequently Asked Questions

What is FDA violation code 117?

117 is an FDA violation code that indicates: "The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.". This violation is based on 502(j), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 117?

According to FDA Import Refusal data, there have been 221 import refusals issued for violation code 117, affecting 74 unique firms.

When was the most recent refusal for violation 117?

The most recent import refusal for violation 117 was on November 20, 2025.

What products are commonly refused for violation 117?

Products commonly refused under violation 117 include: IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE, TOOTHBRUSH, MANUAL, FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), PERCUSSOR, POWERED-ELECTRIC. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 117?

Violation code 117 is based on 502(j), 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.