Green Spike
⚠️ High Risk
FEI: 3009427961 • Dubai • UNITED ARAB EMIRATES
FEI Number
3009427961
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
P O Box 46689, , Dubai, , United Arab Emirates
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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).
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 |
|---|---|---|---|
| 11/22/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 53YG99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 53CG02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 11/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Green Spike's FDA import refusal history?
Green Spike (FEI: 3009427961) has 8 FDA import refusal record(s) in our database, spanning from 11/22/2013 to 11/22/2013.
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. Green Spike's FEI number is 3009427961.
What types of violations has Green Spike received?
Green Spike 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 Green Spike come from?
All FDA import refusal data for Green Spike 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.