Genomma Laboratories
⚠️ High Risk
FEI: 3007507927 • Mexico • MEXICO
FEI Number
3007507927
Location
Mexico
Country
MEXICOAddress
Playa Langosta Ne 194 Col, , Mexico, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2025 | 60CDY09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2022 | 54ADA11HYDROXOCOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2021 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2016 | 62UDL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/15/2016 | 62KIA99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Genomma Laboratories's FDA import refusal history?
Genomma Laboratories (FEI: 3007507927) has 6 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 6/3/2025.
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. Genomma Laboratories's FEI number is 3007507927.
What types of violations has Genomma Laboratories received?
Genomma Laboratories 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 Genomma Laboratories come from?
All FDA import refusal data for Genomma Laboratories 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.