Violation Code: 477
FDA Violation
Charge Code: HOLES
Violation Details
- Violation Code (ASC ID)
- 477
- Charge Code
- HOLES
- Description
- The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
- Legal Section
- 501(c); 801(a)(3) Adulteration
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/12/2026 | GLOVE, PATIENT EXAMINATION, LATEX 80LYY | Medical Glove Company LimitedTHAILAND |
| 12/11/2025 | CONDOM 85HIS | Suretex, Ltd.THAILAND |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 11/12/2025 | GLOVE, PATIENT EXAMINATION, VINYL 80LYZ | |
| 10/21/2025 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Dr.Boo LtdTHAILAND |
| 10/21/2025 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Dr.Boo LtdTHAILAND |
| 10/10/2025 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | Encompass Industries Sdn. Bhd.MALAYSIA |
Related Violations
Other violations under the same legal section: 501(c); 801(a)(3) Adulteration
Frequently Asked Questions
What is FDA violation code 477?
477 is an FDA violation code that indicates: "The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.". This violation is based on 501(c); 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 477?
According to FDA Import Refusal data, there have been 2800 import refusals issued for violation code 477, affecting 409 unique firms.
When was the most recent refusal for violation 477?
The most recent import refusal for violation 477 was on January 12, 2026.
What products are commonly refused for violation 477?
Products commonly refused under violation 477 include: GLOVE, PATIENT EXAMINATION, LATEX, CONDOM, GLOVE, PATIENT EXAMINATION, VINYL. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 477?
Violation code 477 is based on 501(c); 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.