Gigante Recem Nascido Ltda
⚠️ Moderate Risk
FEI: 3004706886 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3004706886
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Almirante Americo dos Reis 604, , 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).
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 |
|---|---|---|---|
| 11/1/2004 | 80MEAPUMP, INFUSION, PCA | Division of Southeast Imports (DSEI) | |
| 11/1/2004 | 89MOCCUSHION, FLOTATION, THERAPEUTIC | Division of Southeast Imports (DSEI) | |
| 11/1/2004 | 80MIOLIGHT, THERAPY, SAD(SEASONAL AFFECTIVE DISORDER) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gigante Recem Nascido Ltda's FDA import refusal history?
Gigante Recem Nascido Ltda (FEI: 3004706886) has 3 FDA import refusal record(s) in our database, spanning from 11/1/2004 to 11/1/2004.
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. Gigante Recem Nascido Ltda's FEI number is 3004706886.
What types of violations has Gigante Recem Nascido Ltda received?
Gigante Recem Nascido Ltda 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 Gigante Recem Nascido Ltda come from?
All FDA import refusal data for Gigante Recem Nascido 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.