Pakmail Valle De Bravo
⚠️ High Risk
FEI: 3005889999 • Valle De Bravovalle De Bravo • MEXICO
FEI Number
3005889999
Location
Valle De Bravovalle De Bravo
Country
MEXICOAddress
Porfiniodiaz #101 Local Ccol Centro, , Valle De Bravovalle De Bravo, , 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).
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 |
|---|---|---|---|
| 1/18/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 60LCL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 64LCJ19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 61XBA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/9/2007 | 54AGK99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/9/2007 | 54AFP05VITAMIN B12 (CYANOCOBALAMIN) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pakmail Valle De Bravo's FDA import refusal history?
Pakmail Valle De Bravo (FEI: 3005889999) has 9 FDA import refusal record(s) in our database, spanning from 2/9/2007 to 1/18/2008.
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. Pakmail Valle De Bravo's FEI number is 3005889999.
What types of violations has Pakmail Valle De Bravo received?
Pakmail Valle De Bravo 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 Pakmail Valle De Bravo come from?
All FDA import refusal data for Pakmail Valle De Bravo 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.