Mediphacos Ltda
⚠️ Moderate Risk
FEI: 3004981643 • Belo Honzonte • BRAZIL
FEI Number
3004981643
Location
Belo Honzonte
Country
BRAZILAddress
Av Deputado Cristavom Chiaradia, , Belo Honzonte, , Brazil
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2014 | 86HQLLENS, INTRAOCULAR | Division of Southeast Imports (DSEI) | |
| 8/23/2013 | 86LZTIMPLANT, INTRACORNEAL | New Orleans District Office (NOL-DO) | |
| 6/11/2012 | 86LQEIMPLANT, CORNEAL, REFRACTIVE | New Orleans District Office (NOL-DO) | |
| 10/27/2011 | 86LQEIMPLANT, CORNEAL, REFRACTIVE | New Orleans District Office (NOL-DO) | |
| 8/5/2011 | 86ODKCORNEAL, REFRACTIVE, IMPLANT | New Orleans District Office (NOL-DO) | |
| 10/24/2005 | 86LYXMEDIA, CORNEAL STORAGE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 9/28/2005 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/28/2005 | 86HJBINSTRUMENT, MEASURING, CORNEAL RADIUS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/28/2005 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/28/2005 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mediphacos Ltda's FDA import refusal history?
Mediphacos Ltda (FEI: 3004981643) has 10 FDA import refusal record(s) in our database, spanning from 9/28/2005 to 8/22/2014.
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. Mediphacos Ltda's FEI number is 3004981643.
What types of violations has Mediphacos Ltda received?
Mediphacos Ltda has been cited for 5 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 Mediphacos Ltda come from?
All FDA import refusal data for Mediphacos Ltda 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.