CI LAYMAR LTDA
⚠️ Moderate Risk
FEI: 2000029787 • Bogota, Cundinamarca • COLOMBIA
FEI Number
2000029787
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Cra 45 A # 104 A - 23, , Bogota, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2012 | 41BCT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 324NO ENGLISH | New York District Office (NYK-DO) |
| 4/6/2011 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 10/16/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 344WARNINGS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is CI LAYMAR LTDA's FDA import refusal history?
CI LAYMAR LTDA (FEI: 2000029787) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2009 to 3/31/2012.
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. CI LAYMAR LTDA's FEI number is 2000029787.
What types of violations has CI LAYMAR LTDA received?
CI LAYMAR LTDA 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 CI LAYMAR LTDA come from?
All FDA import refusal data for CI LAYMAR LTDA 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.