Violation Code: 3362
FDA Violation
Charge Code: NUTR UNIT
Violation Details
- Violation Code (ASC ID)
- 3362
- Charge Code
- NUTR UNIT
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.
- Legal Section
- 403(f), 801(a)(3); MISBRANDED
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Maabarot Products Ltd. | Ma'Abarot, ISRAEL | 25 |
| 2 | Holle Baby Food GmbH | Riehen, SWITZERLAN | 3 |
| 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 | HOLLE FOOD | Riehen, SWITZERLAN | 1 |
| 7 | Laboratoires Guigoz | Marne LA Vallee Cedex 2, FRANCE | 1 |
| 8 | LISA SCHOLTEN | Ittervoort, NETHERLAND | 1 |
| 9 | Mead Johnson & Company, LLC | Evansville, UNITED STA | 1 |
| 10 | NIG Nutritionals Limited - Paerata | Pukekohe, NEW ZEALAN | 1 |
| 11 | Abbott Laboratories B.V. | Zwolle, NETHERLAND | 1 |
| 12 | SAM BODE | Ittervoort, NETHERLAND | 1 |
| 13 | GERMAN NUTRITION GMBH | Munich, GERMANY | 1 |
| 14 | GOLDEN HEART LTD | Tel Aviv, ISRAEL | 1 |
| 15 | Hipp | Hurst Grove, UNITED KIN | 1 |
| 16 | Hipp Uk Ltd | Berkshire, UNITED KIN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/22/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYY01 | HOLLE FOODSWITZERLAN |
| 8/22/2025 | OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED 40NYY99 | 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 |
| 1/30/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PMT01 | SAM BODENETHERLAND |
| 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 |
| 12/18/2023 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PMT01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 11/6/2023 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Kendal Nutricare Ltd.UNITED KIN |
| 8/1/2023 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PFT01 | HippUNITED KIN |
| 6/21/2023 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PFT01 | NIG Nutritionals Limited - PaerataNEW ZEALAN |
| 7/14/2022 | FILLED MILK, DRIED MILK TYPE PRODUCT 14AYN06 | LISA SCHOLTENNETHERLAND |
| 6/21/2022 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Kendal Nutricare Ltd.UNITED KIN |
| 4/15/2022 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYY01 | GERMAN NUTRITION GMBHGERMANY |
| 3/9/2020 | BABY AND JUNIOR FOOD N.E.C. 40YYY99 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 9/27/2017 | CEREAL, N.E.C. (BABY) 40BEE99 | Nestle (Gh) LtdGHANA |
Frequently Asked Questions
What is FDA violation code 3362?
3362 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 be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.". This violation is based on 403(f), 801(a)(3); MISBRANDED of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3362?
According to FDA Import Refusal data, there have been 46 import refusals issued for violation code 3362, affecting 16 unique firms.
When was the most recent refusal for violation 3362?
The most recent import refusal for violation 3362 was on August 22, 2025.
What products are commonly refused for violation 3362?
Products commonly refused under violation 3362 include: MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA, OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED, OTHER FORMULA PRODUCTS FOR SAMPLE TESTING (NOT FOR SALE), N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3362?
Violation code 3362 is based on 403(f), 801(a)(3); MISBRANDED 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.