Thermafat Sa De Cvb
⚠️ Moderate Risk
FEI: 3005060960 • San Pedro Garza Garcia, Nuevo Leon • MEXICO
FEI Number
3005060960
Location
San Pedro Garza Garcia, Nuevo Leon
Country
MEXICOAddress
Calle Rio Madeira Ptecol Del Valle 511, Col. Del Valle, San Pedro Garza Garciaagarcia, San Pedro Garza Garcia, Nuevo Leon, Mexico
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
Refusal History
Frequently Asked Questions
What is Thermafat Sa De Cvb's FDA import refusal history?
Thermafat Sa De Cvb (FEI: 3005060960) has 1 FDA import refusal record(s) in our database, spanning from 5/12/2005 to 5/12/2005.
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. Thermafat Sa De Cvb's FEI number is 3005060960.
What types of violations has Thermafat Sa De Cvb received?
Thermafat Sa De Cvb has been cited for 3 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 Thermafat Sa De Cvb come from?
All FDA import refusal data for Thermafat Sa De Cvb 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.