ORGANIC BABY FOOD GMBH
⚠️ Moderate Risk
FEI: 3013295633 • Hanover, Lower Saxony • GERMANY
FEI Number
3013295633
Location
Hanover, Lower Saxony
Country
GERMANYAddress
Mengendamm 6, , Hanover, Lower Saxony, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
INCONSPICU
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2019 | 40NFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 10/29/2019 | 40NFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 10/29/2019 | 40PFH99OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 10/10/2017 | 40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 10/10/2017 | 40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | 256INCONSPICU | Division of Northern Border Imports (DNBI) |
| 7/25/2017 | 40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | 260FALSE | Division of Northern Border Imports (DNBI) |
| 7/3/2017 | 40NGT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ORGANIC BABY FOOD GMBH's FDA import refusal history?
ORGANIC BABY FOOD GMBH (FEI: 3013295633) has 7 FDA import refusal record(s) in our database, spanning from 7/3/2017 to 10/29/2019.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ORGANIC BABY FOOD GMBH's FEI number is 3013295633.
What types of violations has ORGANIC BABY FOOD GMBH received?
ORGANIC BABY FOOD GMBH has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about ORGANIC BABY FOOD GMBH come from?
All FDA import refusal data for ORGANIC BABY FOOD GMBH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.