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Friesland Campina

⚠️ Moderate Risk

FEI: 3010045788 • Amersfoort, Utrecht • NETHERLANDS

FEI

FEI Number

3010045788

📍

Location

Amersfoort, Utrecht

🇳🇱
🏢

Address

Stationsplein 4, , Amersfoort, Utrecht, Netherlands

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
4
Unique Violations
11/15/2013
Latest Refusal
6/12/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3246×

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.

3093×

FORBIDDEN

The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.

4733×

LABELING

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

Refusal History

DateProductViolationsDivision
11/15/2013
34BYY09MILK CHOCOLATE, SWEET MILK CHOCOLATE AND COATING (EXCEPT CHOCOLATE CANDY AND CHOCOLATE BEVERAGE BASE
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
7/10/2013
40MGT99INFANT FORMULA RAW MATERIAL COMPONENT, N.E.C.,
309FORBIDDEN
324NO ENGLISH
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
7/10/2013
40MGT99INFANT FORMULA RAW MATERIAL COMPONENT, N.E.C.,
309FORBIDDEN
324NO ENGLISH
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
7/10/2013
40MGT99INFANT FORMULA RAW MATERIAL COMPONENT, N.E.C.,
309FORBIDDEN
324NO ENGLISH
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/21/2013
40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
324NO ENGLISH
New York District Office (NYK-DO)
6/12/2013
40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
324NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Friesland Campina's FDA import refusal history?

Friesland Campina (FEI: 3010045788) has 6 FDA import refusal record(s) in our database, spanning from 6/12/2013 to 11/15/2013.

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. Friesland Campina's FEI number is 3010045788.

What types of violations has Friesland Campina received?

Friesland Campina 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 Friesland Campina come from?

All FDA import refusal data for Friesland Campina 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.