Zotzmann Stahl G
⚠️ Moderate Risk
FEI: 3011689482 • Berglen, Baden-Wurttemberg • GERMANY
FEI Number
3011689482
Location
Berglen, Baden-Wurttemberg
Country
GERMANYAddress
Daimlerstr. 10, , Berglen, Baden-Wurttemberg, 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
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2020 | 73CBFCHAMBER, HYPERBARIC | Division of Southeast Imports (DSEI) | |
| 11/3/2020 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 10/8/2020 | 80LRJDISINFECTANT, MEDICAL DEVICES | Division of Southeast Imports (DSEI) | |
| 12/11/2019 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 12/3/2019 | 73CBFCHAMBER, HYPERBARIC | Division of Southeast Imports (DSEI) | |
| 12/3/2019 | 80CAKMICROFILTER, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 12/3/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 12/3/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 12/3/2019 | 80KDQBOTTLE, COLLECTION, VACUUM | Division of Southeast Imports (DSEI) | |
| 5/25/2016 | 55PY02OLIVE OIL (PHARMACEUTIC NECESSITY) | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 79FGYCANNULA, INJECTION | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 75JRLUNIT, FILTER, MEMBRANE | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 80FMHCONTAINER, SPECIMEN | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 80GAZTUBING, NONINVASIVE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zotzmann Stahl G's FDA import refusal history?
Zotzmann Stahl G (FEI: 3011689482) has 14 FDA import refusal record(s) in our database, spanning from 5/25/2016 to 11/20/2020.
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. Zotzmann Stahl G's FEI number is 3011689482.
What types of violations has Zotzmann Stahl G received?
Zotzmann Stahl G has been cited for 7 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 Zotzmann Stahl G come from?
All FDA import refusal data for Zotzmann Stahl G 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.