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Milupa GmbH Co. KG

✅ Low Risk

FEI: 3002809505 • Friedrichsdorf, Hesse • GERMANY

FEI

FEI Number

3002809505

📍

Location

Friedrichsdorf, Hesse

🇩🇪

Country

GERMANY
🏢

Address

Bahnstr. 14-30, , Friedrichsdorf, Hesse, Germany

Low Risk

FDA Import Risk Assessment

22.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

5
Total Refusals
5
Unique Violations
12/23/2016
Latest Refusal
6/20/2008
Earliest Refusal

Score Breakdown

Violation Severity
33.9×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
5.9×10%
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

3244×

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)).

4824×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

3213×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

2561×

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)).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
12/23/2016
40PHT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
256INCONSPICU
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/27/2014
40DCE99VEGETABLES, N.E.C. (BABY)
321LACKS N/C
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/27/2014
40PGE01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
321LACKS N/C
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/27/2014
40PGE01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
321LACKS N/C
324NO ENGLISH
New Orleans District Office (NOL-DO)
6/20/2008
40CHT99FORMULA PRODUCTS (MILK AND MILK SUBSTITUTES) (BABY)
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Milupa GmbH Co. KG's FDA import refusal history?

Milupa GmbH Co. KG (FEI: 3002809505) has 5 FDA import refusal record(s) in our database, spanning from 6/20/2008 to 12/23/2016.

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. Milupa GmbH Co. KG's FEI number is 3002809505.

What types of violations has Milupa GmbH Co. KG received?

Milupa GmbH Co. KG has been cited for 5 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 Milupa GmbH Co. KG come from?

All FDA import refusal data for Milupa GmbH Co. KG 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.