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General Logistics

⚠️ Moderate Risk

FEI: 3003854774 • Neuerstein • GERMANY

FEI

FEI Number

3003854774

📍

Location

Neuerstein

🇩🇪

Country

GERMANY
🏢

Address

17 Parel, , Neuerstein, , Germany

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

6
Total Refusals
8
Unique Violations
10/2/2006
Latest Refusal
10/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
45.5×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
20.3×10%
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

3243×

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)).

2182×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
10/2/2006
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
New Orleans District Office (NOL-DO)
9/8/2005
66VBB99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
472NO ENGLISH
483DRUG NAME
New Orleans District Office (NOL-DO)
11/19/2004
79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
118NOT LISTED
New Orleans District Office (NOL-DO)
12/3/2003
28KCE02GARLIC SALT, GROUND, CRACKED
324NO ENGLISH
New Orleans District Office (NOL-DO)
12/3/2003
28YCY99SPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C.
218LIST INGRE
324NO ENGLISH
New Orleans District Office (NOL-DO)
10/17/2003
54YBB03CHLORELLA (TABLET), VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
218LIST INGRE
324NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is General Logistics's FDA import refusal history?

General Logistics (FEI: 3003854774) has 6 FDA import refusal record(s) in our database, spanning from 10/17/2003 to 10/2/2006.

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. General Logistics's FEI number is 3003854774.

What types of violations has General Logistics received?

General Logistics has been cited for 8 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 General Logistics come from?

All FDA import refusal data for General Logistics 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.