Biocosmetica Excel Argentina S.R.L.
⚠️ Moderate Risk
FEI: 3003918735 • San Justo, Buenos Aires • ARGENTINA
FEI Number
3003918735
Location
San Justo, Buenos Aires
Country
ARGENTINAAddress
Avenida Presidente Doctor Arturo Humberto Illia 1983, , San Justo, Buenos Aires, Argentina
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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).
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 |
|---|---|---|---|
| 7/2/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 9/21/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/17/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 330UNSAFE COL | Florida District Office (FLA-DO) |
| 11/17/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/31/2005 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Biocosmetica Excel Argentina S.R.L.'s FDA import refusal history?
Biocosmetica Excel Argentina S.R.L. (FEI: 3003918735) has 5 FDA import refusal record(s) in our database, spanning from 5/31/2005 to 7/2/2013.
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. Biocosmetica Excel Argentina S.R.L.'s FEI number is 3003918735.
What types of violations has Biocosmetica Excel Argentina S.R.L. received?
Biocosmetica Excel Argentina S.R.L. 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 Biocosmetica Excel Argentina S.R.L. come from?
All FDA import refusal data for Biocosmetica Excel Argentina S.R.L. 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.