Olidef Cz Industria E Comercio
⚠️ Moderate Risk
FEI: 3004114257 • Ribeirao Preto, SP • BRAZIL
FEI Number
3004114257
Location
Ribeirao Preto, SP
Country
BRAZILAddress
Av Pres Castelo Branco 999, , Ribeirao Preto, SP, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2003 | 80FPLINCUBATOR, NEONATAL TRANSPORT | Florida District Office (FLA-DO) | |
| 9/16/2003 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 9/16/2003 | 80LBIUNIT, NEONATAL PHOTOTHERAPY | Florida District Office (FLA-DO) | |
| 9/16/2003 | 80FRWSCALE, PATIENT | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Olidef Cz Industria E Comercio's FDA import refusal history?
Olidef Cz Industria E Comercio (FEI: 3004114257) has 4 FDA import refusal record(s) in our database, spanning from 9/16/2003 to 9/16/2003.
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. Olidef Cz Industria E Comercio's FEI number is 3004114257.
What types of violations has Olidef Cz Industria E Comercio received?
Olidef Cz Industria E Comercio 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 Olidef Cz Industria E Comercio come from?
All FDA import refusal data for Olidef Cz Industria E Comercio 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.