Omnilife Manufactura S.A. de C.V.
⚠️ High Risk
FEI: 3004267218 • Guadalajara, MX-JAL • MEXICO
FEI Number
3004267218
Location
Guadalajara, MX-JAL
Country
MEXICOAddress
Av. Inglaterra No. 3089, Colonia Vallarta Poniente, Guadalajara, MX-JAL, 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 |
|---|---|---|---|
| 11/4/2024 | 62FDJ38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Omnilife Manufactura S.A. de C.V.'s FDA import refusal history?
Omnilife Manufactura S.A. de C.V. (FEI: 3004267218) has 1 FDA import refusal record(s) in our database, spanning from 11/4/2024 to 11/4/2024.
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. Omnilife Manufactura S.A. de C.V.'s FEI number is 3004267218.
What types of violations has Omnilife Manufactura S.A. de C.V. received?
Omnilife Manufactura S.A. de C.V. 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 Omnilife Manufactura S.A. de C.V. come from?
All FDA import refusal data for Omnilife Manufactura S.A. 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.