DIRECT DERMA SUPPLIES
⚠️ Moderate Risk
FEI: 3012681870 • COPENHAGEN • DENMARK
FEI Number
3012681870
Location
COPENHAGEN
Country
DENMARKAddress
OERESTEAD BLVD 73, , COPENHAGEN, , Denmark
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).
MFR INJ
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2019 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 9/14/2016 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Florida District Office (FLA-DO) | |
| 9/14/2016 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is DIRECT DERMA SUPPLIES's FDA import refusal history?
DIRECT DERMA SUPPLIES (FEI: 3012681870) has 3 FDA import refusal record(s) in our database, spanning from 9/14/2016 to 8/30/2019.
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. DIRECT DERMA SUPPLIES's FEI number is 3012681870.
What types of violations has DIRECT DERMA SUPPLIES received?
DIRECT DERMA SUPPLIES 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 DIRECT DERMA SUPPLIES come from?
All FDA import refusal data for DIRECT DERMA SUPPLIES 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.