Violation Code: 3661
FDA Violation
Charge Code: INADQ PAST
Violation Details
- Violation Code (ASC ID)
- 3661
- Charge Code
- INADQ PAST
- Description
- The article is subject to refusal of admission pursuant to section 801 (a)(1) in that it appears to have been manufactured or processed under insanitary conditions which may result in unpasteurized or inadequately pasteurized product.
- Legal Section
- 402(a)(4), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | ASADEROS LA PONDEROSA | Juarez, MEXICO | 1 |
| 2 | BREGO FOR FOOD INDUSTRIES | Al Qahira, EGYPT | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/6/2017 | BUTTER OIL 09ACO02 | |
| 3/7/2013 | CHEESE, HISPANIC/LATINO/MEXICAN STYLE, ALL VARIETIES, INCLUDING QUESO 12CGO13 | ASADEROS LA PONDEROSAMEXICO |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3661?
3661 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801 (a)(1) in that it appears to have been manufactured or processed under insanitary conditions which may result in unpasteurized or inadequately pasteurized product.". This violation is based on 402(a)(4), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3661?
According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 3661, affecting 2 unique firms.
When was the most recent refusal for violation 3661?
The most recent import refusal for violation 3661 was on June 6, 2017.
What products are commonly refused for violation 3661?
Products commonly refused under violation 3661 include: BUTTER OIL, CHEESE, HISPANIC/LATINO/MEXICAN STYLE, ALL VARIETIES, INCLUDING QUESO. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3661?
Violation code 3661 is based on 402(a)(4), 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.