Dr. Otto Suwelack Nachf. GmbH & Co. KG
⚠️ Moderate Risk
FEI: 1000171579 • Billerbeck, North Rhine-Westphalia • GERMANY
FEI Number
1000171579
Location
Billerbeck, North Rhine-Westphalia
Country
GERMANYAddress
Josef-Suwelack-Strasse, , Billerbeck, North Rhine-Westphalia, 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
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).
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.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
Refusal History
Frequently Asked Questions
What is Dr. Otto Suwelack Nachf. GmbH & Co. KG's FDA import refusal history?
Dr. Otto Suwelack Nachf. GmbH & Co. KG (FEI: 1000171579) has 2 FDA import refusal record(s) in our database, spanning from 6/8/2004 to 8/26/2009.
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. Dr. Otto Suwelack Nachf. GmbH & Co. KG's FEI number is 1000171579.
What types of violations has Dr. Otto Suwelack Nachf. GmbH & Co. KG received?
Dr. Otto Suwelack Nachf. GmbH & Co. KG has been cited for 3 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 Dr. Otto Suwelack Nachf. GmbH & Co. KG come from?
All FDA import refusal data for Dr. Otto Suwelack Nachf. 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.