Laboratorios De Cosmetica Avanzada
⚠️ Moderate Risk
FEI: 3007006463 • Ciudad Autonoma Buenos Aires, Buenos Aires • ARGENTINA
FEI Number
3007006463
Location
Ciudad Autonoma Buenos Aires, Buenos Aires
Country
ARGENTINAAddress
Avenida Directorio 455, , Ciudad Autonoma Buenos Aires, 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
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53GG01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/12/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New Orleans District Office (NOL-DO) | |
| 2/9/2009 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 2/9/2009 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 2/9/2009 | 62WAL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/9/2009 | 62NCJ99ANTI-PSORIATIC N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios De Cosmetica Avanzada's FDA import refusal history?
Laboratorios De Cosmetica Avanzada (FEI: 3007006463) has 14 FDA import refusal record(s) in our database, spanning from 2/9/2009 to 8/23/2010.
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. Laboratorios De Cosmetica Avanzada's FEI number is 3007006463.
What types of violations has Laboratorios De Cosmetica Avanzada received?
Laboratorios De Cosmetica Avanzada has been cited for 10 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 Laboratorios De Cosmetica Avanzada come from?
All FDA import refusal data for Laboratorios De Cosmetica Avanzada 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.