Violation Code: 509
FDA Violation
Charge Code: NONSTEEL
Violation Details
- Violation Code (ASC ID)
- 509
- Charge Code
- NONSTEEL
- Description
- Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument.
- Legal Section
- 502(a) and/or 502(f)(1); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | ZOT Nederland B.V. Amsterdam, Lugano Branch | Lugano, SWITZERLAN | 1 |
| 2 | Yercon Diagnostic Co Ltd | Changchun, CHINA | 1 |
| 3 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 1 |
| 4 | Mezorrison Health Science & Technology (Shenzhen) Co.,Ltd | Shenzhen, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 7/28/2020 | RESPIRATOR, N95, HOME USE 80NZJ | |
| 7/19/2019 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LC06 | Nouvelle Parfumeria GandourIVORY COAS |
| 11/2/2012 | KIT, SCREENING, URINE 83JXA | |
| 4/11/2002 | STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING 89NGX |
Frequently Asked Questions
What is FDA violation code 509?
509 is an FDA violation code that indicates: "Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument.". This violation is based on 502(a) and/or 502(f)(1); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 509?
According to FDA Import Refusal data, there have been 4 import refusals issued for violation code 509, affecting 4 unique firms.
When was the most recent refusal for violation 509?
The most recent import refusal for violation 509 was on July 28, 2020.
What products are commonly refused for violation 509?
Products commonly refused under violation 509 include: RESPIRATOR, N95, HOME USE, MOISTURIZING (SKIN CARE PREPARATIONS), KIT, SCREENING, URINE, STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 509?
Violation code 509 is based on 502(a) and/or 502(f)(1); 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.