ImportRefusal LogoImportRefusal

Violation Code: 288

FDA Violation

Charge Code: STD LABEL

45
Total Refusals
35
Affected Firms
11/20/2025
Latest Case
5/15/2002
First Case

Violation Details

Violation Code (ASC ID)
288
Charge Code
STD LABEL
Description
The article appears to not bear labeling prescribed by the performance standard established under section 514.
Legal Section
502(s), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1New GPC Inc.East Bank Demerara, GUYANA4
2Washington Surgical InternationalSialkot, PAKISTAN3
3Oritech Electronics Corp. Suite 7, 9Taipei, TAIWAN2
4Ladycare Lifetime LtdBristol, UNITED KIN2
5Daeyang Medical Co LtdMunmak-eup, SOUTH KORE2
6Glory Hill IndustrialDongguan, CHINA2
7United Towel ExportersKarachi, PAKISTAN2
8HANGZHOU DINGYU ELECTRONIC CO.,LTDNingbo, CHINA1
9HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTDYiyang, CHINA1
10JINAN ARTSIGN SCIENCE & TECHNOLOJinan, CHINA1
11Lee Chao ChangTaoyuan, TAIWAN1
12Max Concept Technology Ltd.North Point, HONG KONG1
13MIU LABZHEJIANG, CHINA1
14NINGBO ZHONGXIN ELECTRONICSNingbo, CHINA1
15Oritech InternationalAllama Iqbal Town Defense Road, PAKISTAN1
16RIMOS SRLMirandola, ITALY1
17Shanghai Care US Medical Product Co., LtdShanghai, CHINA1
18Shanxi Hongjin Plastic Technology Co., LtdLinfen, CHINA1
19S. M. Jaleel & Company LimitedSouth Oropouche, TRINIDAD A1
20Sometech IncorporatedSeoul, SOUTH KORE1

Recent Import Refusals

DateProductFirm
11/20/2025
TAPE AND BANDAGE, ADHESIVE
79KGX
Shanghai Care US Medical Product Co., LtdCHINA
9/2/2025
SCISSORS, GENERAL USE, SURGICAL
79LRW
Washington Surgical InternationalPAKISTAN
9/2/2025
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Washington Surgical InternationalPAKISTAN
9/2/2025
FORCEPS, GENERAL & PLASTIC SURGERY
79GEN
Washington Surgical InternationalPAKISTAN
1/8/2025
CLEANERS, MEDICAL DEVICES
80MDZ
YJK TECHNOLOGY(SHENZHEN) CO.,LIMCHINA
10/16/2024
POWERED LASER SURGICAL INSTRUMENTS
79GEX
WEIFANG MINGLIANG ELECTRONICS COCHINA
1/30/2024
GLOVE, PATIENT EXAMINATION, VINYL
80LYZ
Shanxi Hongjin Plastic Technology Co., LtdCHINA
3/29/2022
GOWN, PATIENT
80FYB
United Towel ExportersPAKISTAN
3/29/2022
GOWN, PATIENT
80FYB
United Towel ExportersPAKISTAN
9/1/2020
LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
95RES
HANGZHOU DINGYU ELECTRONIC CO.,LTDCHINA
8/18/2020
THERMOMETER KIT
80PXH
HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTDCHINA
7/23/2020
THERMOMETER KIT
80PXH
ZHENG KANG TECHNOLOGY CO., LTDCHINA
7/6/2020
RESPIRATOR, SURGICAL
80MSH
DONGGUAN LEIHUO MEDICAL DEVICE CO LTDCHINA
2/19/2020
LAMP, INFRARED, THERAPEUTIC HEATING
89ILY
Ching Ming Medical Device Co., Ltd.TAIWAN
5/28/2019
FORCEPS
79HTD
HANGZHOU BUS LOGISTICS TECHNOLOGCHINA

Frequently Asked Questions

What is FDA violation code 288?

288 is an FDA violation code that indicates: "The article appears to not bear labeling prescribed by the performance standard established under section 514.". This violation is based on 502(s), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 288?

According to FDA Import Refusal data, there have been 45 import refusals issued for violation code 288, affecting 35 unique firms.

When was the most recent refusal for violation 288?

The most recent import refusal for violation 288 was on November 20, 2025.

What products are commonly refused for violation 288?

Products commonly refused under violation 288 include: TAPE AND BANDAGE, ADHESIVE, SCISSORS, GENERAL USE, SURGICAL, FORCEPS, GENERAL & PLASTIC SURGERY, CLEANERS, MEDICAL DEVICES. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 288?

Violation code 288 is based on 502(s), 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.