Distribuidora Denise Lyda
⚠️ High Risk
FEI: 3003983403 • Belo Orizonte • BRAZIL
FEI Number
3003983403
Location
Belo Orizonte
Country
BRAZILAddress
Rua Jaboticabol Nova Granada, , Belo Orizonte, , Brazil
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2003 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3000N-RX INACT | Florida District Office (FLA-DO) |
| 9/3/2003 | 85HHDPAD, MENSTRUAL, UNSCENTED | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 62FAL17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 292SUBSTITUTE | Florida District Office (FLA-DO) |
| 9/3/2003 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Distribuidora Denise Lyda's FDA import refusal history?
Distribuidora Denise Lyda (FEI: 3003983403) has 14 FDA import refusal record(s) in our database, spanning from 9/3/2003 to 9/3/2003.
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. Distribuidora Denise Lyda's FEI number is 3003983403.
What types of violations has Distribuidora Denise Lyda received?
Distribuidora Denise Lyda 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 Distribuidora Denise Lyda come from?
All FDA import refusal data for Distribuidora Denise Lyda 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.