Beiersdorf Manufacturing Tres Cantos
⚠️ Moderate Risk
FEI: 3010307603 • Tres Cantos, Madrid • SPAIN
FEI Number
3010307603
Location
Tres Cantos, Madrid
Country
SPAINAddress
Avd. De La Industria 31, , Tres Cantos, Madrid, Spain
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Northeast Imports (DNEI) | |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Northeast Imports (DNEI) | |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Northeast Imports (DNEI) | |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Beiersdorf Manufacturing Tres Cantos's FDA import refusal history?
Beiersdorf Manufacturing Tres Cantos (FEI: 3010307603) has 5 FDA import refusal record(s) in our database, spanning from 9/26/2025 to 10/14/2025.
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. Beiersdorf Manufacturing Tres Cantos's FEI number is 3010307603.
What types of violations has Beiersdorf Manufacturing Tres Cantos received?
Beiersdorf Manufacturing Tres Cantos 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 Beiersdorf Manufacturing Tres Cantos come from?
All FDA import refusal data for Beiersdorf Manufacturing Tres Cantos 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.