Novamed Fabricacao De Produtos Farmaceuticas LTDA.
⚠️ Moderate Risk
FEI: 3016607359 • Manuas • 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is Novamed Fabricacao De Produtos Farmaceuticas LTDA.'s FDA import refusal history?
Novamed Fabricacao De Produtos Farmaceuticas LTDA. (FEI: 3016607359) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2022 to 10/12/2022.
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. Novamed Fabricacao De Produtos Farmaceuticas LTDA.'s FEI number is 3016607359.
What types of violations has Novamed Fabricacao De Produtos Farmaceuticas LTDA. received?
Novamed Fabricacao De Produtos Farmaceuticas 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 Novamed Fabricacao De Produtos Farmaceuticas LTDA. come from?
All FDA import refusal data for Novamed Fabricacao De Produtos Farmaceuticas 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.