Pak Mail De Occidente Sa De Cv
⚠️ Moderate Risk
FEI: 3006213127 • Guadalajaraguadalajara • MEXICO
FEI Number
3006213127
Location
Guadalajaraguadalajara
Country
MEXICOAddress
Morelos No 557centroguadalajara, , Guadalajaraguadalajara, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2008 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/25/2008 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/25/2008 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/25/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/25/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pak Mail De Occidente Sa De Cv's FDA import refusal history?
Pak Mail De Occidente Sa De Cv (FEI: 3006213127) has 5 FDA import refusal record(s) in our database, spanning from 3/25/2008 to 3/25/2008.
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. Pak Mail De Occidente Sa De Cv's FEI number is 3006213127.
What types of violations has Pak Mail De Occidente Sa De Cv received?
Pak Mail De Occidente Sa De Cv has been cited for 1 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 Mail De Occidente Sa De Cv come from?
All FDA import refusal data for Pak Mail De Occidente 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.