Omni Manufacturing
⚠️ Moderate Risk
FEI: 3011655232 • Queretaro • MEXICO
FEI Number
3011655232
Location
Queretaro
Country
MEXICOAddress
Mz, La Noria Lt 13, Queretaro, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2019 | 79KOXSOLVENT, ADHESIVE TAPE | Division of Southeast Imports (DSEI) | |
| 7/16/2019 | 79GCDCONNECTOR, CATHETER | Division of Southeast Imports (DSEI) | |
| 7/16/2019 | 79GCDCONNECTOR, CATHETER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Omni Manufacturing's FDA import refusal history?
Omni Manufacturing (FEI: 3011655232) has 3 FDA import refusal record(s) in our database, spanning from 7/16/2019 to 7/16/2019.
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. Omni Manufacturing's FEI number is 3011655232.
What types of violations has Omni Manufacturing received?
Omni Manufacturing 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 Omni Manufacturing come from?
All FDA import refusal data for Omni Manufacturing 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.