Violation Code: 3160
FDA Violation
Charge Code: NONRSP-VER
Violation Details
- Violation Code (ASC ID)
- 3160
- Charge Code
- NONRSP-VER
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this thermally processed low acid food packaged in a hermetically sealed container pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public health.
- Legal Section
- 402(a)(4), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/25/2018 | SHRIMP PASTE, FISHERY PRODUCTS, N.E.C. 16YCE12 | Global Food Solutions, IncorporatedPHILIPPINE |
| 2/2/2018 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS 21VEE48 | Procesadora San Martin de PorresDOMINICAN |
| 2/24/2017 | MUSHROOM, COMMON (AGARICUS BISPORUS), PIECES AND STEMS, SLICED 25QCE01 | Okechamp B.V.NETHERLAND |
| 8/12/2015 | GINGER ROOT, DRIED OR PASTE 25LCI24 | |
| 4/15/2015 | PIGEON PEAS 24AEE17 | Procesadora SACPERU |
| 5/14/2014 | PALM NUT (PALM FRUIT, SUGAR PALM), JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VEE24 | |
| 5/6/2014 | BEAN CURD, N.E.C. (MULTIPLE FOOD SPECIALTIES, SIDE DISHES & DESSERTS) 37BCE32 | |
| 5/6/2014 | BAMBOO SHOOTS (LEAF & STEM VEGETABLE) 24TCE03 | |
| 11/25/2013 | NONCARBONATED SOFT DRINK, N.E.C. 29ACI99 | |
| 5/10/2013 | COCONUT, PASTE 23DEE05 | Envasados Comestibles, S.A. (ENCOSA)DOMINICAN |
| 4/19/2013 | TRUFFLE, FUNGI PRODUCTS, N.E.C. 25SCE02 | SAVINI TARTUFI SRLITALY |
| 1/25/2012 | SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. 29YHI99 | Woong Jin Foods Co., LtdSOUTH KORE |
| 1/25/2012 | SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. 29YHI99 | Woong Jin Foods Co., LtdSOUTH KORE |
| 1/13/2012 | PIT FRUIT, N.E.C. 21GCF99 | Conservas y Congelados YAESTA, S.A.GUATEMALA |
| 1/13/2012 | HEART OF PALM (LEAF & STEM VEGETABLE) 24TCI39 | Conservas y Congelados YAESTA, S.A.GUATEMALA |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3160?
3160 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this thermally processed low acid food packaged in a hermetically sealed container pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public health.". 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 3160?
According to FDA Import Refusal data, there have been 35 import refusals issued for violation code 3160, affecting 24 unique firms.
When was the most recent refusal for violation 3160?
The most recent import refusal for violation 3160 was on September 25, 2018.
What products are commonly refused for violation 3160?
Products commonly refused under violation 3160 include: SHRIMP PASTE, FISHERY PRODUCTS, N.E.C., COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS, MUSHROOM, COMMON (AGARICUS BISPORUS), PIECES AND STEMS, SLICED, GINGER ROOT, DRIED OR PASTE, PIGEON PEAS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3160?
Violation code 3160 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.