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Roquette Freres

⚠️ High Risk

FEI: 1000114558 • Lestrem, Pas-de-calais • FRANCE

FEI

FEI Number

1000114558

📍

Location

Lestrem, Pas-de-calais

🇫🇷

Country

FRANCE
🏢

Address

1 Rue De La Haute Loge, , Lestrem, Pas-de-calais, France

High Risk

FDA Import Risk Assessment

56.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

24
Total Refusals
4
Unique Violations
8/9/2021
Latest Refusal
5/10/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.4×40%
Refusal Volume
51.8×30%
Recency
11.5×20%
Frequency
25.9×10%
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

372113×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

2419×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/9/2021
02FFT08GLUTEN, WHEAT
241PESTICIDE
Division of Northeast Imports (DNEI)
7/29/2021
02FFT08GLUTEN, WHEAT
241PESTICIDE
Division of Northeast Imports (DNEI)
3/23/2020
63XCZ83MANNITOL (DIAGNOSTIC AID) (DRUGS)
3280FRNMFGREG
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/28/2017
18YFY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
241PESTICIDE
Division of Southeast Imports (DSEI)
4/10/2017
02FFH08GLUTEN, WHEAT
241PESTICIDE
Division of Northeast Imports (DNEI)
1/11/2017
02FFT08GLUTEN, WHEAT
241PESTICIDE
Division of West Coast Imports (DWCI)
12/23/2016
02FFH08GLUTEN, WHEAT
241PESTICIDE
Division of Southeast Imports (DSEI)
8/10/2016
02FFT08GLUTEN, WHEAT
241PESTICIDE
Chicago District Office (CHI-DO)
8/10/2016
02FFT08GLUTEN, WHEAT
241PESTICIDE
Chicago District Office (CHI-DO)
8/10/2016
02FFT08GLUTEN, WHEAT
241PESTICIDE
Chicago District Office (CHI-DO)
2/22/2016
02FFH08GLUTEN, WHEAT
3721PESTICIDE2
Florida District Office (FLA-DO)
10/1/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Division of Northeast Imports (DNEI)
10/1/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Division of Northeast Imports (DNEI)
10/1/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Division of Northeast Imports (DNEI)
10/1/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Division of Northeast Imports (DNEI)
10/1/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Division of Northeast Imports (DNEI)
9/17/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Chicago District Office (CHI-DO)
9/17/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Chicago District Office (CHI-DO)
8/11/2015
02FFT08GLUTEN, WHEAT
3721PESTICIDE2
Southwest Import District Office (SWI-DO)
7/6/2015
02FFH08GLUTEN, WHEAT
3721PESTICIDE2
Florida District Office (FLA-DO)
6/19/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
3280FRNMFGREG
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/29/2012
02FFH08GLUTEN, WHEAT
3721PESTICIDE2
Los Angeles District Office (LOS-DO)
5/10/2012
02FFH08GLUTEN, WHEAT
3721PESTICIDE2
Seattle District Office (SEA-DO)
5/10/2012
02FFH08GLUTEN, WHEAT
3721PESTICIDE2
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Roquette Freres's FDA import refusal history?

Roquette Freres (FEI: 1000114558) has 24 FDA import refusal record(s) in our database, spanning from 5/10/2012 to 8/9/2021.

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. Roquette Freres's FEI number is 1000114558.

What types of violations has Roquette Freres received?

Roquette Freres 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 Roquette Freres come from?

All FDA import refusal data for Roquette Freres 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.