Laboratory Heel Colombia
✅ Low Risk
FEI: 3008983624 • Bogota • COLOMBIA
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2011 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 7/28/2011 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 7/28/2011 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratory Heel Colombia's FDA import refusal history?
Laboratory Heel Colombia (FEI: 3008983624) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.
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. Laboratory Heel Colombia's FEI number is 3008983624.
What types of violations has Laboratory Heel Colombia received?
Laboratory Heel Colombia has been cited for 2 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 Laboratory Heel Colombia come from?
All FDA import refusal data for Laboratory Heel Colombia 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.