Violation Code: 3361
FDA Violation
Charge Code: NUTR DEF
Violation Details
- Violation Code (ASC ID)
- 3361
- Charge Code
- NUTR DEF
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100
- Legal Section
- 412(a)(1), 801(a)(3); Adulterated
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Maabarot Products Ltd. | Ma'Abarot, ISRAEL | 22 |
| 2 | Holle Baby Food GmbH | Riehen, SWITZERLAN | 9 |
| 3 | Hipp GmbH & CO Vertrieb KG | Pfaffenhofen A.d.ilm, GERMANY | 3 |
| 4 | Kendal Nutricare Ltd. | Kendal, UNITED KIN | 2 |
| 5 | Nestle (Gh) Ltd | North Dzorwulu, GHANA | 2 |
| 6 | Hipp | Hurst Grove, UNITED KIN | 1 |
| 7 | HOLLE FOOD | Riehen, SWITZERLAN | 1 |
| 8 | Potentia Trium B.V | Rotterdam, NETHERLAND | 1 |
| 9 | LISA SCHOLTEN | Ittervoort, NETHERLAND | 1 |
| 10 | Mondizen | LA Cote St Andre, FRANCE | 1 |
| 11 | THE LITTLEOAK COMPANY PTY CO | Byron Bay, AUSTRALIA | 1 |
| 12 | GOLDEN HEART LTD | Tel Aviv, ISRAEL | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/5/2025 | OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA 40PYY99 | Holle Baby Food GmbHSWITZERLAN |
| 12/5/2025 | OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA 40PYY99 | Holle Baby Food GmbHSWITZERLAN |
| 10/27/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYP01 | HOLLE FOODSWITZERLAN |
| 9/4/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 7/17/2024 | TODDLER GOAT MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULA 40PGY11 | Holle Baby Food GmbHSWITZERLAN |
| 3/26/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 2/21/2024 | OTHER FORMULA PRODUCTS FOR SAMPLE TESTING (NOT FOR SALE), N.E.C. 40RYT99 | Holle Baby Food GmbHSWITZERLAN |
| 1/12/2024 | GOAT MILK BASED INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED 40NCY05 | Holle Baby Food GmbHSWITZERLAN |
| 1/10/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Kendal Nutricare Ltd.UNITED KIN |
| 1/8/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Holle Baby Food GmbHSWITZERLAN |
| 1/8/2024 | WHEY BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET03 | Holle Baby Food GmbHSWITZERLAN |
| 8/1/2023 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PFT01 | HippUNITED KIN |
| 7/31/2023 | OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA 40PYY99 | THE LITTLEOAK COMPANY PTY COAUSTRALIA |
| 12/12/2022 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PGT01 | Holle Baby Food GmbHSWITZERLAN |
| 12/12/2022 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PGT01 | Holle Baby Food GmbHSWITZERLAN |
Frequently Asked Questions
What is FDA violation code 3361?
3361 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100". This violation is based on 412(a)(1), 801(a)(3); Adulterated of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3361?
According to FDA Import Refusal data, there have been 45 import refusals issued for violation code 3361, affecting 12 unique firms.
When was the most recent refusal for violation 3361?
The most recent import refusal for violation 3361 was on December 5, 2025.
What products are commonly refused for violation 3361?
Products commonly refused under violation 3361 include: OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA, MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA, TODDLER GOAT MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULA. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3361?
Violation code 3361 is based on 412(a)(1), 801(a)(3); Adulterated 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.