Violation Code: 3161
FDA Violation
Charge Code: NONRSP-PRC
Violation Details
- Violation Code (ASC ID)
- 3161
- Charge Code
- NONRSP-PRC
- Description
- The article 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 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
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | IMURAYA SEIKA CO.,LTD. | Tsu, JAPAN | 10 |
| 2 | HOC GUAN MANUFACTURING CORPORATION | Malabon, PHILIPPINE | 6 |
| 3 | N.a. Food Products Co.,ltd | Nakhon Pathom, THAILAND | 4 |
| 4 | Bennett Opie Ltd | Sittingbourne, UNITED KIN | 4 |
| 5 | Charlie Brown di Rutigliano & Figli S.r.l. | Binetto, ITALY | 4 |
| 6 | Boscovivo s.n.c. | Civitella In Val Di Chiana, ITALY | 3 |
| 7 | Hong Chi Food Co., Ltd. | Changhua, TAIWAN | 3 |
| 8 | Yeo Hiap Seng (Guangzhou) Food & Beverage Limited | Guangzhou, CHINA | 3 |
| 9 | Chilera Tapatia SA de CV | Tlajomulco De Zuniga, MEXICO | 3 |
| 10 | Rongcheng Shidao Guangxin Food Co., Ltd. | Weihai, CHINA | 2 |
| 11 | Fitrite Incorporated | Quezon City, PHILIPPINE | 2 |
| 12 | Provitus Dabrowscy ,Malesa S.J. | Zambrow, POLAND | 2 |
| 13 | Baltimore Dominicana S.A. | Santiago, DOMINICAN | 2 |
| 14 | GOOD DAY FOODS LTD | THANE (W), INDIA | 2 |
| 15 | Conservera de Esteiro, S.A.U. | Muros, SPAIN | 2 |
| 16 | Raisio Nutrition Ltd | Raisio, FINLAND | 1 |
| 17 | Sahachol Food Supplies Co., Ltd. | Si Racha, THAILAND | 1 |
| 18 | Salsa Huichol S. de R.L. de C.V. | Xalisco, MEXICO | 1 |
| 19 | San Carlos Conservera Sa De Cv | San Carlos, MEXICO | 1 |
| 20 | SANGARIA | Iga, JAPAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/31/2017 | CARROT TOPS (LEAF & STEM VEGETABLE) 24TYE09 | |
| 8/31/2017 | HORSERADISH, PREPARED 27YCE04 | |
| 6/24/2016 | OLIVES, GREEN, (PIT FRUIT) 21GCI11 | Bennett Opie LtdUNITED KIN |
| 6/24/2016 | OLIVES, GREEN, (PIT FRUIT) 21GCI11 | Bennett Opie LtdUNITED KIN |
| 6/24/2016 | OLIVES, GREEN, (PIT FRUIT) 21GCI11 | Bennett Opie LtdUNITED KIN |
| 6/24/2016 | OLIVES, GREEN, (PIT FRUIT) 21GCI11 | Bennett Opie LtdUNITED KIN |
| 10/14/2015 | BEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE) 24BEI99 | Good Morning Seoul Corp.SOUTH KORE |
| 9/28/2015 | SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C. 03REE99 | GOOD DAY FOODS LTDINDIA |
| 8/12/2015 | GARLIC BULB, DRIED OR PASTE 25LYI21 | |
| 12/10/2014 | PEPPER SAUCE (HOT, MILD, ETC.) 27YGI06 | |
| 8/20/2014 | BAMBOO SHOOTS (LEAF & STEM VEGETABLE) 24TEE03 | |
| 11/21/2013 | MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') 16AEE73 | |
| 11/21/2013 | MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') 16AEE73 | |
| 10/24/2013 | PALM SEED (TODDY) (SUBTROPICAL/TROPICAL FRUIT PULP) 21XME23 | |
| 8/1/2013 | VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. 25YDF99 |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3161?
3161 is an FDA violation code that indicates: "The article 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 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 3161?
According to FDA Import Refusal data, there have been 74 import refusals issued for violation code 3161, affecting 37 unique firms.
When was the most recent refusal for violation 3161?
The most recent import refusal for violation 3161 was on August 31, 2017.
What products are commonly refused for violation 3161?
Products commonly refused under violation 3161 include: CARROT TOPS (LEAF & STEM VEGETABLE), HORSERADISH, PREPARED, OLIVES, GREEN, (PIT FRUIT). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3161?
Violation code 3161 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.