Laboratorios L.O. Oftalmi, C.A.
⚠️ Moderate Risk
FEI: 3003571292 • Caracas, D.F. • VENEZUELA
FEI Number
3003571292
Location
Caracas, D.F.
Country
VENEZUELAAddress
Ca.�Leo 6, Zona Industrial de La Urbina, Caracas, D.F., Venezuela
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).
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).
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 |
|---|---|---|---|
| 8/8/2024 | 61EDY08LORATADINE (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/1/2009 | 62GCK35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/21/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/14/2005 | 60CIK46NAPHAZOLINE HCL (ADRENERGIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios L.O. Oftalmi, C.A.'s FDA import refusal history?
Laboratorios L.O. Oftalmi, C.A. (FEI: 3003571292) has 4 FDA import refusal record(s) in our database, spanning from 9/14/2005 to 8/8/2024.
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. Laboratorios L.O. Oftalmi, C.A.'s FEI number is 3003571292.
What types of violations has Laboratorios L.O. Oftalmi, C.A. received?
Laboratorios L.O. Oftalmi, C.A. has been cited for 3 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 Laboratorios L.O. Oftalmi, C.A. come from?
All FDA import refusal data for Laboratorios L.O. Oftalmi, C.A. 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.