Pak Leon Sa De Cv
⚠️ Moderate Risk
FEI: 3005958721 • Leon De Los Aldama, Guanajuato • MEXICO
FEI Number
3005958721
Location
Leon De Los Aldama, Guanajuato
Country
MEXICOAddress
Boulevard Adolfo Lopez Mateos Poniente 2321-2, Col. Jardines Del Moral, Leon, Leon De Los Aldama, Guanajuato, 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/19/2009 | 62GCY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/19/2009 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 1/15/2008 | 62UBL20DEXTROMETHORPHAN POLISTIREX (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/15/2008 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pak Leon Sa De Cv's FDA import refusal history?
Pak Leon Sa De Cv (FEI: 3005958721) has 4 FDA import refusal record(s) in our database, spanning from 1/15/2008 to 5/19/2009.
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. Pak Leon Sa De Cv's FEI number is 3005958721.
What types of violations has Pak Leon Sa De Cv received?
Pak Leon Sa De Cv 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 Pak Leon Sa De Cv come from?
All FDA import refusal data for Pak Leon 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.