Aruba Aloe Balm N.V.
⚠️ Moderate Risk
FEI: 3004117460 • Oranjestad • ARUBA
FEI Number
3004117460
Location
Oranjestad
Country
ARUBAAddress
Pitastraat 115, , Oranjestad, , Aruba
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
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 |
|---|---|---|---|
| 5/25/2017 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 7/25/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 9/7/2010 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 9/7/2010 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 9/7/2010 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 6/28/2010 | 66P07OXYBENZONE (ULTRAVIOLET SCREEN) | 336INCONSPICU | Detroit District Office (DET-DO) |
| 6/28/2010 | 60QAJ67LIDOCAINE (ANESTHETIC) | 336INCONSPICU | Detroit District Office (DET-DO) |
| 6/28/2010 | 66P07OXYBENZONE (ULTRAVIOLET SCREEN) | Detroit District Office (DET-DO) | |
| 6/28/2010 | 66P07OXYBENZONE (ULTRAVIOLET SCREEN) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/27/2010 | 79MGQDRESSING, WOUND AND BURN, HYDROGEL | Detroit District Office (DET-DO) | |
| 5/27/2010 | 60QAK07LIDOCAINE | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Aruba Aloe Balm N.V.'s FDA import refusal history?
Aruba Aloe Balm N.V. (FEI: 3004117460) has 16 FDA import refusal record(s) in our database, spanning from 5/27/2010 to 5/25/2017.
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. Aruba Aloe Balm N.V.'s FEI number is 3004117460.
What types of violations has Aruba Aloe Balm N.V. received?
Aruba Aloe Balm N.V. has been cited for 6 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 Aruba Aloe Balm N.V. come from?
All FDA import refusal data for Aruba Aloe Balm N.V. 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.