SR-WHOLESALE
⚠️ Moderate Risk
FEI: 3015976772 • Schijndel, Noord-Brabant • NETHERLANDS
FEI Number
3015976772
Location
Schijndel, Noord-Brabant
Country
NETHERLANDSAddress
Edisonweg 25, , Schijndel, Noord-Brabant, Netherlands
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
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).
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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2019 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | Division of Southeast Imports (DSEI) | |
| 12/16/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/16/2019 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/16/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SR-WHOLESALE's FDA import refusal history?
SR-WHOLESALE (FEI: 3015976772) has 4 FDA import refusal record(s) in our database, spanning from 12/16/2019 to 12/16/2019.
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. SR-WHOLESALE's FEI number is 3015976772.
What types of violations has SR-WHOLESALE received?
SR-WHOLESALE 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 SR-WHOLESALE come from?
All FDA import refusal data for SR-WHOLESALE 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.