Mensajeros Radio Worldwide C A
⚠️ Moderate Risk
FEI: 1000397143 • Caracas • VENEZUELA
FEI Number
1000397143
Location
Caracas
Country
VENEZUELAAddress
Calle Atapabo Con Orinoco, , Caracas, , Venezuela
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
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).
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).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2005 | 54ABA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 6/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 62VIA30INDINAVIR SULFATE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 62VDB32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/8/2002 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 2/25/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/19/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mensajeros Radio Worldwide C A's FDA import refusal history?
Mensajeros Radio Worldwide C A (FEI: 1000397143) has 11 FDA import refusal record(s) in our database, spanning from 2/19/2002 to 11/3/2005.
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. Mensajeros Radio Worldwide C A's FEI number is 1000397143.
What types of violations has Mensajeros Radio Worldwide C A received?
Mensajeros Radio Worldwide C 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 Mensajeros Radio Worldwide C A come from?
All FDA import refusal data for Mensajeros Radio Worldwide C 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.