BAUTZ ENGINEERING GES.MBH
✅ Low Risk
FEI: 3013884970 • Stromberg, Rhineland-Palatinate • GERMANY
FEI Number
3013884970
Location
Stromberg, Rhineland-Palatinate
Country
GERMANYAddress
Postfach 101, , Stromberg, Rhineland-Palatinate, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
Refusal History
Frequently Asked Questions
What is BAUTZ ENGINEERING GES.MBH's FDA import refusal history?
BAUTZ ENGINEERING GES.MBH (FEI: 3013884970) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2017 to 11/20/2017.
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. BAUTZ ENGINEERING GES.MBH's FEI number is 3013884970.
What types of violations has BAUTZ ENGINEERING GES.MBH received?
BAUTZ ENGINEERING GES.MBH has been cited for 2 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 BAUTZ ENGINEERING GES.MBH come from?
All FDA import refusal data for BAUTZ ENGINEERING GES.MBH 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.