Violation Code: 288
FDA Violation
Charge Code: STD LABEL
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 Name | Location | Cases |
|---|---|---|---|
| 1 | New GPC Inc. | East Bank Demerara, GUYANA | 4 |
| 2 | Washington Surgical International | Sialkot, PAKISTAN | 3 |
| 3 | United Towel Exporters | Karachi, PAKISTAN | 2 |
| 4 | Glory Hill Industrial | Dongguan, CHINA | 2 |
| 5 | Oritech Electronics Corp. Suite 7, 9 | Taipei, TAIWAN | 2 |
| 6 | Ladycare Lifetime Ltd | Bristol, UNITED KIN | 2 |
| 7 | Daeyang Medical Co Ltd | Munmak-eup, SOUTH KORE | 2 |
| 8 | Turner and Wrights Ltd | Bolton, UNITED KIN | 1 |
| 9 | Wuipo Plastic Toy Manufactory | Dongguan, CHINA | 1 |
| 10 | GOLD MINTS PRODUCTS CO. LTD. | Bangkok, THAILAND | 1 |
| 11 | Specialist Clobal Protection Corp | Boston, UNITED STA | 1 |
| 12 | Guangzhou Qijun Electronic Techn | Guangzhou City, CHINA | 1 |
| 13 | Compania Nacional de Chocolates | Rionegro, COLOMBIA | 1 |
| 14 | Shanghai Care US Medical Product Co., Ltd | Shanghai, CHINA | 1 |
| 15 | Trade Avail | Cape Town, SOUTH AFRI | 1 |
| 16 | TREE GROUP., LIMITED | Kowloon Bay, HONG KONG | 1 |
| 17 | JINAN ARTSIGN SCIENCE & TECHNOLO | Jinan, CHINA | 1 |
| 18 | NINGBO ZHONGXIN ELECTRONICS | Ningbo, CHINA | 1 |
| 19 | Shanxi Hongjin Plastic Technology Co., Ltd | Linfen, CHINA | 1 |
| 20 | MIU LAB | ZHEJIANG, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/20/2025 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 9/2/2025 | SCISSORS, GENERAL USE, SURGICAL 79LRW | |
| 9/2/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 9/2/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 1/8/2025 | CLEANERS, MEDICAL DEVICES 80MDZ | |
| 10/16/2024 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | |
| 1/30/2024 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 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 | |
| 8/18/2020 | THERMOMETER KIT 80PXH | |
| 7/23/2020 | THERMOMETER KIT 80PXH | |
| 7/6/2020 | RESPIRATOR, SURGICAL 80MSH | |
| 2/19/2020 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 5/28/2019 | FORCEPS 79HTD |
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.