Beiersdorf Sa
⚠️ Moderate Risk
FEI: 3003652686 • Saniago • CHILE
FEI Number
3003652686
Location
Saniago
Country
CHILEAddress
Camino La Espejo 501, , Saniago, , Chile
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2021 | 62HCY99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2010 | 53BC01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 473LABELING | Florida District Office (FLA-DO) |
| 3/26/2010 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 473LABELING | Florida District Office (FLA-DO) |
| 3/26/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Florida District Office (FLA-DO) |
| 3/26/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Beiersdorf Sa's FDA import refusal history?
Beiersdorf Sa (FEI: 3003652686) has 5 FDA import refusal record(s) in our database, spanning from 3/26/2010 to 8/17/2021.
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 Sa's FEI number is 3003652686.
What types of violations has Beiersdorf Sa received?
Beiersdorf Sa has been cited for 2 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 Sa come from?
All FDA import refusal data for Beiersdorf Sa 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.