Farmace - Industria Quimico-Farmaceutica Cearense Ltda.
⚠️ Moderate Risk
FEI: 3014958961 • Barbalha, Ceara • BRAZIL
FEI Number
3014958961
Location
Barbalha, Ceara
Country
BRAZILAddress
Rodovia Doutor Antonio Lirio Calou, CALLOU KM 02, Barbalha, Ceara, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Farmace - Industria Quimico-Farmaceutica Cearense Ltda.'s FDA import refusal history?
Farmace - Industria Quimico-Farmaceutica Cearense Ltda. (FEI: 3014958961) has 2 FDA import refusal record(s) in our database, spanning from 9/30/2025 to 9/30/2025.
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. Farmace - Industria Quimico-Farmaceutica Cearense Ltda.'s FEI number is 3014958961.
What types of violations has Farmace - Industria Quimico-Farmaceutica Cearense Ltda. received?
Farmace - Industria Quimico-Farmaceutica Cearense Ltda. has been cited for 3 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 Farmace - Industria Quimico-Farmaceutica Cearense Ltda. come from?
All FDA import refusal data for Farmace - Industria Quimico-Farmaceutica Cearense 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.