Bel Star S.A.
⚠️ Moderate Risk
FEI: 3003840061 • Tocancipa, Cundinamarca • COLOMBIA
FEI Number
3003840061
Location
Tocancipa, Cundinamarca
Country
COLOMBIAAddress
Parque Industrial Canavita, Verada Canavita Km 22 Autopista Norte, Tocancipa, Cundinamarca, Colombia
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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
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 |
|---|---|---|---|
| 1/7/2014 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 9/19/2013 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 9/19/2013 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 336INCONSPICU | New Orleans District Office (NOL-DO) |
| 9/19/2013 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 9/19/2013 | 66PBR07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/16/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/16/2013 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 1/22/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/7/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 1/14/2005 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Bel Star S.A.'s FDA import refusal history?
Bel Star S.A. (FEI: 3003840061) has 10 FDA import refusal record(s) in our database, spanning from 1/14/2005 to 1/7/2014.
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. Bel Star S.A.'s FEI number is 3003840061.
What types of violations has Bel Star S.A. received?
Bel Star S.A. has been cited for 7 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 Bel Star S.A. come from?
All FDA import refusal data for Bel Star 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.