GM DOS REIS Industria E Comercio Ltda
⚠️ Moderate Risk
FEI: 3013756169 • Campinas, Sao Paulo • BRAZIL
FEI Number
3013756169
Location
Campinas, Sao Paulo
Country
BRAZILAddress
Avenida Pierre Simon De Laplace, 600, , Campinas, 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).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2022 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Division of Southeast Imports (DSEI) | |
| 5/24/2022 | 79GAOSUTURE, NONABSORBABLE | Division of Southeast Imports (DSEI) | |
| 5/16/2022 | 87JDPIMPLANT, FIXATION DEVICE, CONDYLAR PLATE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GM DOS REIS Industria E Comercio Ltda's FDA import refusal history?
GM DOS REIS Industria E Comercio Ltda (FEI: 3013756169) has 3 FDA import refusal record(s) in our database, spanning from 5/16/2022 to 6/15/2022.
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. GM DOS REIS Industria E Comercio Ltda's FEI number is 3013756169.
What types of violations has GM DOS REIS Industria E Comercio Ltda received?
GM DOS REIS Industria E Comercio Ltda has been cited for 4 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 GM DOS REIS Industria E Comercio Ltda come from?
All FDA import refusal data for GM DOS REIS Industria E Comercio 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.