Industrias Chamer S.A. de C.V.
⚠️ Moderate Risk
FEI: 3010163972 • San Pedro Sula, Cortes • HONDURAS
FEI Number
3010163972
Location
San Pedro Sula, Cortes
Country
HONDURASAddress
Km 1 Autopista La Lima, , San Pedro Sula, Cortes, Honduras
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 Industrias Chamer S.A. de C.V.'s FDA import refusal history?
Industrias Chamer S.A. de C.V. (FEI: 3010163972) has 3 FDA import refusal record(s) in our database, spanning from 10/9/2020 to 12/22/2020.
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. Industrias Chamer S.A. de C.V.'s FEI number is 3010163972.
What types of violations has Industrias Chamer S.A. de C.V. received?
Industrias Chamer S.A. de C.V. 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 Industrias Chamer S.A. de C.V. come from?
All FDA import refusal data for Industrias Chamer S.A. de C.V. 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.