Violation Code: 2160
FDA Violation
Charge Code: LACK NOTIF
Violation Details
- Violation Code (ASC ID)
- 2160
- Charge Code
- LACK NOTIF
- Description
- Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).
- Legal Section
- 301(s)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Hipp GmbH & CO Vertrieb KG | Pfaffenhofen A.d.ilm, GERMANY | 9 |
| 2 | THE LITTLEOAK COMPANY PTY CO | Byron Bay, AUSTRALIA | 8 |
| 3 | Nutricia NV | Zoetermeer, NETHERLAND | 6 |
| 4 | NIG Nutritionals Limited - Paerata | Pukekohe, NEW ZEALAN | 5 |
| 5 | Holle Baby Food GmbH | Riehen, SWITZERLAN | 4 |
| 6 | HOLLE FOOD | Riehen, SWITZERLAN | 3 |
| 7 | Potentia Trium B.V | Rotterdam, NETHERLAND | 3 |
| 8 | H J Heinz Company Limited | Kendal, UNITED KIN | 1 |
| 9 | Marion Meinel | Konfgsdorf, GERMANY | 1 |
| 10 | M VANDERHELM N VANDERHELM | Southport, AUSTRALIA | 1 |
| 11 | NESTLE GHANA LTD | Tema, GHANA | 1 |
| 12 | New Zealand New Milk | Auckland, NEW ZEALAN | 1 |
| 13 | New Zealand New Milk | Auckland, NEW ZEALAN | 1 |
| 14 | NUTRICIA GMBH | Erlangen, GERMANY | 1 |
| 15 | Nutricia Ltd. | Auckland, NEW ZEALAN | 1 |
| 16 | Perrigo Wisconsin, LLC | Eau Claire, UNITED STA | 1 |
| 17 | Quality Home Products | Concord, CANADA | 1 |
| 18 | Remitente Laboratorios Ordesa S.L. | Barcelonabarcelona, SPAIN | 1 |
| 19 | Shaked Tevel Ltd | Moshav Batzra, ISRAEL | 1 |
| 20 | Alk-abello A/s | Horsholm, DENMARK | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/13/2026 | WHEY BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED 40NYY03 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 12/3/2025 | OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED 40NYY99 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 11/26/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PFT01 | COCOONCENTERFRANCE |
| 11/12/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYY01 | |
| 10/31/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED 40NYH01 | NUTRICIA GMBHGERMANY |
| 10/27/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYP01 | HOLLE FOODSWITZERLAN |
| 9/24/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 7/21/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Holle Baby Food GmbHSWITZERLAN |
| 7/21/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Holle Baby Food GmbHSWITZERLAN |
| 7/21/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Holle Baby Food GmbHSWITZERLAN |
| 7/21/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Holle Baby Food GmbHSWITZERLAN |
| 4/9/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PGT01 | HOLLE FOODSWITZERLAN |
| 4/9/2025 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PFT01 | HOLLE FOODSWITZERLAN |
| 11/5/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 11/5/2024 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PYT01 | Hipp GmbH & CO Vertrieb KGGERMANY |
Frequently Asked Questions
What is FDA violation code 2160?
2160 is an FDA violation code that indicates: "Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).". This violation is based on 301(s) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2160?
According to FDA Import Refusal data, there have been 58 import refusals issued for violation code 2160, affecting 27 unique firms.
When was the most recent refusal for violation 2160?
The most recent import refusal for violation 2160 was on January 13, 2026.
What products are commonly refused for violation 2160?
Products commonly refused under violation 2160 include: WHEY BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED, OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED, MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA, MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2160?
Violation code 2160 is based on 301(s) 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.