Pak Aguascalientes
⚠️ High Risk
FEI: 3005939754 • Guadalajaraguadalajara • MEXICO
FEI Number
3005939754
Location
Guadalajaraguadalajara
Country
MEXICOAddress
Av, Americas 1201fracc Santa Elena,, , Guadalajaraguadalajara, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 11/3/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 62GCA94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 56BAE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/3/2006 | 60LAA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pak Aguascalientes's FDA import refusal history?
Pak Aguascalientes (FEI: 3005939754) has 7 FDA import refusal record(s) in our database, spanning from 11/3/2006 to 11/3/2006.
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 Aguascalientes's FEI number is 3005939754.
What types of violations has Pak Aguascalientes received?
Pak Aguascalientes 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 Aguascalientes come from?
All FDA import refusal data for Pak Aguascalientes 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.