Nivea
⚠️ Moderate Risk
FEI: 3003612890 • Hamburg • 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/2/2010 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 6/2/2010 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/2/2010 | 62WBQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nivea's FDA import refusal history?
Nivea (FEI: 3003612890) has 13 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 6/2/2010.
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. Nivea's FEI number is 3003612890.
What types of violations has Nivea received?
Nivea has been cited for 4 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 Nivea come from?
All FDA import refusal data for Nivea 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.