NIRVEL SL
⚠️ Moderate Risk
FEI: 3012919428 • Alcoy, Alicante • SPAIN
FEI Number
3012919428
Location
Alcoy, Alicante
Country
SPAINAddress
Pol Ind Cotes Baixes, , Alcoy, Alicante, 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
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/28/2014 | 53FD02HAIR TINTS (HAIR COLORING PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 3/21/2014 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/21/2014 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/21/2014 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/21/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/21/2014 | 53FC02HAIR TINTS (HAIR COLORING PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 2/21/2014 | 53FC02HAIR TINTS (HAIR COLORING PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 2/21/2014 | 53FC02HAIR TINTS (HAIR COLORING PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 2/21/2014 | 53FC02HAIR TINTS (HAIR COLORING PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 2/21/2014 | 53FC02HAIR TINTS (HAIR COLORING PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 10/22/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/22/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/10/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 330UNSAFE COL | Florida District Office (FLA-DO) |
| 2/10/2010 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 330UNSAFE COL | Florida District Office (FLA-DO) |
| 2/10/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 330UNSAFE COL | Florida District Office (FLA-DO) |
| 2/10/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/10/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/10/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/23/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is NIRVEL SL's FDA import refusal history?
NIRVEL SL (FEI: 3012919428) has 20 FDA import refusal record(s) in our database, spanning from 5/23/2008 to 4/3/2015.
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. NIRVEL SL's FEI number is 3012919428.
What types of violations has NIRVEL SL received?
NIRVEL SL 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 NIRVEL SL come from?
All FDA import refusal data for NIRVEL SL 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.