Thermo Group, C.A
⚠️ Moderate Risk
FEI: 3004526661 • Miranda, Carabobo • VENEZUELA
FEI Number
3004526661
Location
Miranda, Carabobo
Country
VENEZUELAAddress
Avenida Zona Industrial De Este 2, , Miranda, Carabobo, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/23/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/23/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Thermo Group, C.A's FDA import refusal history?
Thermo Group, C.A (FEI: 3004526661) has 3 FDA import refusal record(s) in our database, spanning from 6/23/2008 to 6/23/2008.
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. Thermo Group, C.A's FEI number is 3004526661.
What types of violations has Thermo Group, C.A received?
Thermo Group, C.A 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 Thermo Group, C.A come from?
All FDA import refusal data for Thermo Group, 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.