Laboratories Dermanat S.A.
⚠️ High Risk
FEI: 3012767098 • Yumbo, Valle Del Cauca • COLOMBIA
FEI Number
3012767098
Location
Yumbo, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 32 7 19, , Yumbo, Valle Del Cauca, Colombia
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
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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2024 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/6/2022 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/6/2021 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 9/26/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/5/2015 | 60LBY99ANALGESIC, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/7/2014 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/7/2007 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratories Dermanat S.A.'s FDA import refusal history?
Laboratories Dermanat S.A. (FEI: 3012767098) has 12 FDA import refusal record(s) in our database, spanning from 11/7/2007 to 8/2/2024.
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. Laboratories Dermanat S.A.'s FEI number is 3012767098.
What types of violations has Laboratories Dermanat S.A. received?
Laboratories Dermanat S.A. 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 Laboratories Dermanat S.A. come from?
All FDA import refusal data for Laboratories Dermanat S.A. 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.