BRAINFARMA INDUSTRIA QUIMICA E F
⚠️ Moderate Risk
FEI: 3012701555 • ANAPOLIS, Sao Paulo • BRAZIL
FEI Number
3012701555
Location
ANAPOLIS, Sao Paulo
Country
BRAZILAddress
QUADRA 2 A MODULO 4 DAI, , ANAPOLIS, 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
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 |
|---|---|---|---|
| 4/25/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2017 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2017 | 64LCO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BRAINFARMA INDUSTRIA QUIMICA E F's FDA import refusal history?
BRAINFARMA INDUSTRIA QUIMICA E F (FEI: 3012701555) has 4 FDA import refusal record(s) in our database, spanning from 3/1/2017 to 4/25/2019.
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. BRAINFARMA INDUSTRIA QUIMICA E F's FEI number is 3012701555.
What types of violations has BRAINFARMA INDUSTRIA QUIMICA E F received?
BRAINFARMA INDUSTRIA QUIMICA E F has been cited for 1 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 BRAINFARMA INDUSTRIA QUIMICA E F come from?
All FDA import refusal data for BRAINFARMA INDUSTRIA QUIMICA E F 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.