ImportRefusal LogoImportRefusal

Violation Code: 16

FDA Violation

Charge Code: DIRECTIONS

10,684
Total Refusals
4096
Affected Firms
11/6/2025
Latest Case
10/11/2001
First Case

Violation Details

Violation Code (ASC ID)
16
Charge Code
DIRECTIONS
Description
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Legal Section
502(f)(1), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Bescon Co., Ltd.Cheonan-City, SOUTH KORE295
2Hemani InternationalKarachi, PAKISTAN104
3NATURE REPUBLIC CO., LTD.Seoul, SOUTH KORE94
4California Exotic Novelties, LLCOntario, UNITED STA90
5Lovely PlanetGemenos, FRANCE81
6Johnson & Johnson Vision Care, Inc.Jacksonville, UNITED STA80
7CooperVision, Inc.West Henrietta, UNITED STA80
8One World Pharma Pvt. Ltd.Mumbai, INDIA75
9Alcon Research LLCDuluth, UNITED STA69
10SOLOTICA DISTRIBUIDORA DESao Paulo, BRAZIL68
11A & H Design GroupHung Hom, HONG KONG68
12Nouvelle Parfumeria GandourAbidjan 01, IVORY COAS67
13Pd Products LlcWest Hills, UNITED STA67
14Novartis Pharma Stein AGStein Ag, SWITZERLAN67
15Lovehoney-Best GreenDakan Cun, CHINA64
16Danamedic ApsKgs. Lyngby, DENMARK60
17Health Devices Corp. dba Doc Johnson EnterprisesN Hollywood, UNITED STA60
18DreamCon Co. Ltd.Yangsan, SOUTH KORE60
19Dr Irena Eris S.A.Piaseczno, POLAND51
20FarmGroupBarnaul, RUSSIA48

Recent Import Refusals

DateProductFirm
11/6/2025
POWERED LASER SURGICAL INSTRUMENTS
79GEX
ZHENGZHOU BESTVIEW ST CO LTDCHINA
10/22/2025
NEEDLE, SUTURING, DISPOSABLE
79GAB
MEDAX S.R.L. UNIPERSONALEITALY
8/20/2025
POWERED LASER SURGICAL INSTRUMENTS
79GEX
HEBEI KEYLASER SCI-TECH CO., LTD.CHINA
8/20/2025
POWERED LASER SURGICAL INSTRUMENTS
79GEX
HEBEI KEYLASER SCI-TECH CO., LTD.CHINA
8/11/2025
CANNULA, CATHETER
74DQR
YANCHENG DILING MEDICAL INSTRUMECHINA
7/29/2025
AUTOMATED URINALYSIS SYSTEM
75KQO
Kimball Electronics Poland Sp.z O.oPOLAND
7/21/2025
TAPE AND BANDAGE, ADHESIVE
79KGX
ATHENA INNOVATIONCHINA
6/30/2025
LENS, CONTACT (DISPOSABLE)
86MVN
Interojo Inc.SOUTH KORE
5/19/2025
GENERAL PURPOSE REAGENT
88PPM
THE TREND HOTELMALAYSIA
5/6/2025
MISCELLANEOUS PATENT MEDICINES, ETC.
66VDY99
COSMETIQUE ASIA CORPPHILIPPINE
4/18/2025
GENERAL WELLNESS PRODUCT
80PWC
INSIGHT SPINE GMBHGERMANY
4/4/2025
SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT LASER PRODUCTS
95REP
IFAC (HANGZHOU) INTELLIGENT MANUFACTURING CO., LTDCHINA
3/25/2025
LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
79OHS
PREMIER DEAD SEA COSMETICS LABORISRAEL
3/4/2025
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
REVITACAREFRANCE
3/4/2025
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
79LMH
REVITACAREFRANCE

Related Violations

Other violations under the same legal section: 502(f)(1), 801(a)(3); MISBRANDING

CodeCharge CodeCases
2280DIRSEXMPT1322
3871708NODIREC4

Frequently Asked Questions

What is FDA violation code 16?

16 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.". This violation is based on 502(f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 16?

According to FDA Import Refusal data, there have been 10684 import refusals issued for violation code 16, affecting 4096 unique firms.

When was the most recent refusal for violation 16?

The most recent import refusal for violation 16 was on November 6, 2025.

What products are commonly refused for violation 16?

Products commonly refused under violation 16 include: POWERED LASER SURGICAL INSTRUMENTS, NEEDLE, SUTURING, DISPOSABLE, CANNULA, CATHETER. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 16?

Violation code 16 is based on 502(f)(1), 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.