L F Garbelini Otica Me
⚠️ Moderate Risk
FEI: 3007159669 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3007159669
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Do Oratorio 1445, , Sao Paulo, Sao Paulo, 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 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2020 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 2/7/2020 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/8/2020 | 86MZDSYSTEM, IN-OFFICE TINTING, CONTACT LENSES | Division of Southeast Imports (DSEI) | |
| 1/7/2012 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 11/16/2010 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2010 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 10/5/2010 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/2/2009 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/30/2009 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 9/1/2009 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 8/20/2009 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is L F Garbelini Otica Me's FDA import refusal history?
L F Garbelini Otica Me (FEI: 3007159669) has 12 FDA import refusal record(s) in our database, spanning from 8/20/2009 to 8/22/2020.
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. L F Garbelini Otica Me's FEI number is 3007159669.
What types of violations has L F Garbelini Otica Me received?
L F Garbelini Otica Me has been cited for 8 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 L F Garbelini Otica Me come from?
All FDA import refusal data for L F Garbelini Otica Me 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.