W MEDICAL SYSTEMS
⚠️ Moderate Risk
FEI: 3014096012 • Lauenforde, Lower Saxony • GERMANY
FEI Number
3014096012
Location
Lauenforde, Lower Saxony
Country
GERMANYAddress
Lonsstr. 12, , Lauenforde, Lower Saxony, 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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2022 | 28BYY16CUMIN, GROUND, CRACKED (SPICE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2019 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/8/2019 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/29/2018 | 81ORGPLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is W MEDICAL SYSTEMS's FDA import refusal history?
W MEDICAL SYSTEMS (FEI: 3014096012) has 4 FDA import refusal record(s) in our database, spanning from 5/29/2018 to 4/20/2022.
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. W MEDICAL SYSTEMS's FEI number is 3014096012.
What types of violations has W MEDICAL SYSTEMS received?
W MEDICAL SYSTEMS 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 W MEDICAL SYSTEMS come from?
All FDA import refusal data for W MEDICAL SYSTEMS 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.