Promotora Exterior Sa De Cv
⚠️ Moderate Risk
FEI: 3004741752 • Puebla, Puebla • MEXICO
FEI Number
3004741752
Location
Puebla, Puebla
Country
MEXICOAddress
Avenida 10 Poniente 2910-101, Col. VILLA SAN ALEJANDRO, Puebla, Puebla, 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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Promotora Exterior Sa De Cv's FDA import refusal history?
Promotora Exterior Sa De Cv (FEI: 3004741752) has 2 FDA import refusal record(s) in our database, spanning from 11/18/2004 to 3/23/2005.
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. Promotora Exterior Sa De Cv's FEI number is 3004741752.
What types of violations has Promotora Exterior Sa De Cv received?
Promotora Exterior Sa De Cv 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 Promotora Exterior Sa De Cv come from?
All FDA import refusal data for Promotora Exterior Sa De Cv 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.