Inverpal Eu
⚠️ Moderate Risk
FEI: 3009021883 • Barranquilla, Atlantico • COLOMBIA
FEI Number
3009021883
Location
Barranquilla, Atlantico
Country
COLOMBIAAddress
Calle 74 No 75-165, , Barranquilla, Atlantico, 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
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).
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).
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2014 | 89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 8/30/2012 | 53AY02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 8/30/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 8/30/2012 | 62MBL08MENTHOL (ANTI-PRURITIC) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Inverpal Eu's FDA import refusal history?
Inverpal Eu (FEI: 3009021883) has 4 FDA import refusal record(s) in our database, spanning from 8/30/2012 to 5/28/2014.
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. Inverpal Eu's FEI number is 3009021883.
What types of violations has Inverpal Eu received?
Inverpal Eu 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 Inverpal Eu come from?
All FDA import refusal data for Inverpal Eu 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.