Omni Manufacturing Services S.A. de C.V.
⚠️ Moderate Risk
FEI: 3010047442 • Santa Rosa Jauregui, Queretaro • MEXICO
FEI Number
3010047442
Location
Santa Rosa Jauregui, Queretaro
Country
MEXICOAddress
La Noria Lt 13 Mza 125 Parque Industrial, Calle Queretaro Rosa Jauregui; Queretaro, Santa Rosa Jauregui, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2013 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Omni Manufacturing Services S.A. de C.V.'s FDA import refusal history?
Omni Manufacturing Services S.A. de C.V. (FEI: 3010047442) has 1 FDA import refusal record(s) in our database, spanning from 7/23/2013 to 7/23/2013.
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 Services S.A. de C.V.'s FEI number is 3010047442.
What types of violations has Omni Manufacturing Services S.A. de C.V. received?
Omni Manufacturing Services 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 Omni Manufacturing Services S.A. de C.V. come from?
All FDA import refusal data for Omni Manufacturing Services 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.