Krauter Mix GmbH
⚠️ Moderate Risk
FEI: 3004133823 • Abtswind, Bavaria • GERMANY
FEI Number
3004133823
Location
Abtswind, Bavaria
Country
GERMANYAddress
Wiesentheider Str. 4, , Abtswind, Bavaria, 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
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
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:
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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:
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
WRONG IDEN
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 as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2017 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 241PESTICIDE | Division of Northern Border Imports (DNBI) |
| 8/21/2014 | 54KBR03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | 3721PESTICIDE2 | Chicago District Office (CHI-DO) |
| 8/9/2013 | 54JBT03VALERIAN (HERBAL & BOTANICALS II) | 3721PESTICIDE2 | San Francisco District Office (SAN-DO) |
| 8/9/2013 | 54JBT03VALERIAN (HERBAL & BOTANICALS II) | 3721PESTICIDE2 | San Francisco District Office (SAN-DO) |
| 7/29/2013 | 28CYY41SAGE, NATURAL EXTRACT OR FLAVOR (SPICE) | 9SALMONELLA | New Orleans District Office (NOL-DO) |
| 12/20/2012 | 28AAH41SAGE, WHOLE (SPICE) | 9SALMONELLA | New York District Office (NYK-DO) |
| 6/9/2011 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Los Angeles District Office (LOS-DO) |
| 6/17/2010 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Chicago District Office (CHI-DO) |
| 8/16/2004 | 54YFT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Chicago District Office (CHI-DO) | |
| 5/26/2004 | 54FBT55PLANTAIN (E.G., WEED), (HERBAL & BOTANICALS, NOT TEAS) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Krauter Mix GmbH's FDA import refusal history?
Krauter Mix GmbH (FEI: 3004133823) has 10 FDA import refusal record(s) in our database, spanning from 5/26/2004 to 11/29/2017.
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. Krauter Mix GmbH's FEI number is 3004133823.
What types of violations has Krauter Mix GmbH received?
Krauter Mix GmbH has been cited for 10 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 Krauter Mix GmbH come from?
All FDA import refusal data for Krauter Mix 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.