Pak Culiacan
⚠️ Moderate Risk
FEI: 3007207213 • Culiacanculiacan • MEXICO
FEI Number
3007207213
Location
Culiacanculiacan
Country
MEXICOAddress
Ave. Josefa Ortiz De Dmgz 495 Ote 5col., , Culiacanculiacan, , 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 |
|---|---|---|---|
| 4/27/2009 | 56CCH27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2009 | 62GCC41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2009 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pak Culiacan's FDA import refusal history?
Pak Culiacan (FEI: 3007207213) has 3 FDA import refusal record(s) in our database, spanning from 3/13/2009 to 4/27/2009.
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 Culiacan's FEI number is 3007207213.
What types of violations has Pak Culiacan received?
Pak Culiacan 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 Culiacan come from?
All FDA import refusal data for Pak Culiacan 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.