Mail Pack S. De R.L. De C.V.
⚠️ High Risk
FEI: 3005539040 • Guadalajaraguadalajara • MEXICO
FEI Number
3005539040
Location
Guadalajaraguadalajara
Country
MEXICOAddress
Av. Chapultepec No -1ecol. Moderna, , 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).
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 |
|---|---|---|---|
| 2/15/2008 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/15/2008 | 64MCK99GONAD-STIMULATING PRINCIPLE N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/15/2008 | 64MCK99GONAD-STIMULATING PRINCIPLE N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/12/2008 | 64LDA19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/12/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/12/2008 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/12/2008 | 64LCK03BETAMETHASONE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mail Pack S. De R.L. De C.V.'s FDA import refusal history?
Mail Pack S. De R.L. De C.V. (FEI: 3005539040) has 7 FDA import refusal record(s) in our database, spanning from 2/12/2008 to 2/15/2008.
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. Mail Pack S. De R.L. De C.V.'s FEI number is 3005539040.
What types of violations has Mail Pack S. De R.L. De C.V. received?
Mail Pack S. De R.L. De C.V. 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 Mail Pack S. De R.L. De C.V. come from?
All FDA import refusal data for Mail Pack S. De R.L. De C.V. 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.